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Every catheter 510(k), the day FDA posts it.

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Ablation Catheter Surgical Imaging Diagnostic All medical devices

All classes Class I Class II Class III100 entries · live · openFDA

510(k)

Sponsor

Device

Class

Cleared

Scientia Vascular, Inc.

Socrates Aspiration System (Socrates 70 Aspiration Catheter)

Free Flow Medical, Inc.

LungFlow Airway Catheter

MedSource Labs, LLC

MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter

Millipede88 Access Catheter

Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter

Microvention Inc. d/b/a Terumo Neuro

ISAAC Neurovascular Navigation Catheter

Sterilmed, Inc.

Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)

Hangzhou AGS MedTech Co., Ltd.

Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019

Hangzhou Jimushi Meditech Co., Ltd.

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)

Integra Lifesciences Production Corporation

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)

Centerline Biomedical

Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)

MicroVention, Inc., d/b/a Terumo Neuro

BOBBY Balloon Guide Catheter

Balosmark, Inc.

Perfect-O Ostial Positioning Catheter

Bioptimal International Pte. , Ltd.

Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N

WAVE Medical AG

WAVE PTA Balloon Catheter

Suzhou Zenith Vascular SciTech Limited

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set

B.Braun Medical, Inc.

Introcan Safety® Deep Access XL IV Catheter

Elucent Medical

SmartClip Delivery Catheter (ADR-1715)

Asahi Intecc Co., Ltd.

SAYA 86 Radial Access Guide Catheter

Zhejiang Soudon Medical Technology Co., Ltd.

Disposable Stone Retrieval Balloon Catheter

QApel Medical, Inc.

Lynx Aspiration Catheter System

Intervention Tech, Inc. ; dba Corvention

KardiaPSI Balloon Catheter

Mirco-Tech (Nanjing) Co., Ltd.

Dilation Balloon Catheter

Micro-Tech (Nanjing) Co., Ltd.

Visualized Access and Delivery Catheter; PB Digital Controller

OptiMap Catheter - 60mm (OPTI-CATH2-60)

Medtronic Interventional Vascular, Inc.

Liberant RX Aspiration Catheter

Sonorous NV, Inc.

BosCATH Support Catheter

Next Generation 088 Catheter

Maduro Medical, Inc.

Radical 6F Access Catheter

Boston Scientific

OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)

Shanghai MicroPort Medical (Group) Co., Ltd.

Firefighter Pro PTCA Balloon Catheter

Becton Dickinson Infusion Therapy Systems, Inc.

BD Insyte IV Catheter

Convatec Limited

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

Dongguan TT Medical, Inc.

Valvuloplasty Balloon Catheter (ValvuloPro)

OptiMap Catheter - 50mm (OPTI-CATH2-50)

BARE Wireguided Balloon Dilation Catheter (1235)

Liv Pre-lubricated Intermittent Catheter

Free Flow Medical, Inc.

LungFlow Basket Catheter

C.R. Bard, Inc.

Rubber Utility Catheter

Liquet Medical, Inc.

Versus Catheter (VS110-9NB)

Centerline Biomedical, Inc.

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)

Pulmonx Corporation

Chartis Precision Catheter

Armada 14 NC PTA Catheter

Stryker Neurovascular

AXS Lift Intracranial Base Catheter

Argon Medical Devices, Inc.

CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister

Argon Medical Devices, Inc.

VariFuse Adjustable Infusion Catheter

Medtronic, Ireland

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

Toro Neurovascular, Inc.

Toro 88 Superbore Catheter

Medtronic, Inc.

Bio-Medicus Life Support Catheter and Introducer

Imricor Medical Systems, Inc.

Vision-MR Diagnostic Catheter

Jamjoom Fullcare Corporation

Ready to use Nelaton Catheter

Bioteque Corporation

BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

Leadoptik, Inc.

LIA-1 Catheter (542-1)

Terumo Medical Products (Hangzhou) Co., Ltd.

Midline Catheter

Natec Medical , Ltd.

Amethyst HP PTA OTW 0.035 Catheter

Terumo Medical Products (Hangzhou) Co., Ltd.

SURFLO Hybria Closed System Safety IV Catheter

Spectrum Vascular

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)

Surgical Instrument Service and Savings, Inc.

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

Li Medical Corporation , Ltd.

RELIEEV HSG Catheter (HSG7FA1)

Arctx Cool Catheter Set

Imperative Care, Inc.

Zoom System (Zoom 4S Catheter)

Medtronic, Ireland

Telescope Guide Extension Catheter

Volcano Corporation (Dba Philips Image Guided Therapy Device

Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter

Unity Medical, Inc.

VersaD Delivery Catheter

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)

Carrier XL Delivery Catheter

Olympus Medical Systems Corporation

Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)

Becton Dickinson Infusion Therapy Systems, Inc.

BD Saf-T-Intima Subcutaneous Catheter System

Acotec Scientific Co., Ltd.

Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)

AngioSafe, Inc.

Santreva-ATK Endovascular Revasculariztion Catheter

Jupiter Endovascular

Vertex(TM) Catheter

Tangent Endoscopy, LLC

Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller

Prytime Medical Devices, Inc.

pREBOA-PRO Catheter

Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set

Cerenovus, Inc.

CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set

Centerpoint Systems

CPS Locator 3D Delivery Catheter

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

Pipeline Medical Products, LLC

AeroJet Ventilation Catheter

Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

Medical Components, Inc.

14F Duo-Flow® Side X Side Double Lumen Catheter

Integra Lifesciences Production Corporation

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

Integra Lifesciences Production Corporation

Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)

Hangzhou Viction Medical Technology Co.,Ltd

Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)

Access Vascular, Inc.

HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr

Suzhou Zenith Vascular SciTech Limited

Becton Dickinson Infusion Therapy Systems, Inc.

BD Nexiva Closed IV Catheter System

Stereotaxis, Inc.

MAGiC Sweep EP Mapping Catheter

Vitrolife Sweden AB

Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)

Terumo Corporation

DualView Catheter

Surgical Instrument Service and Savings, Inc.

Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

Becton Dickinson Infusion Therapy Systems, Inc.

BD Cathena Safety IV Catheter

Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)

Access Vascular, Inc.

Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)

Primum Hydrophilic Guiding Catheter

Becton Dickinson Infusion Therapy Systems, Inc.

BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter

Boston Scientific Corporation

VIKING Fixed Curve Diagnostic Catheter

CenterPoint Systems, LLC

CPS Locator 3D Plus Delivery Catheter

Chengdu Daxan Innovative Medical Tech. Co., Ltd.

Disposable Intermittent Catheter (TPU Catheter)

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