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FDA Tracker

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

Suzhou Zenith Vascular SciTech Limited

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set

WAVE Medical AG

WAVE PTA Balloon Catheter

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)

BARE Wireguided Balloon Dilation Catheter (1235)

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

Liv Pre-lubricated Intermittent Catheter

Free Flow Medical, Inc.

LungFlow Basket Catheter

C.R. Bard, Inc.

Rubber Utility Catheter

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)

Liquet Medical, Inc.

Versus Catheter (VS110-9NB)

Armada 14 NC PTA Catheter

Pulmonx Corporation

Chartis Precision 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)

Natec Medical , Ltd.

Amethyst HP PTA OTW 0.035 Catheter

Terumo Medical Products (Hangzhou) Co., Ltd.

Midline 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

Carrier XL Delivery Catheter

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

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

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)

Stereotaxis, Inc.

MAGiC Sweep EP Mapping Catheter

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

Access Vascular, Inc.

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

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)

Primum Hydrophilic Guiding Catheter

CenterPoint Systems, LLC

CPS Locator 3D Plus Delivery Catheter

Boston Scientific Corporation

VIKING Fixed Curve Diagnostic 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

Chengdu Daxan Innovative Medical Tech. Co., Ltd.

Disposable Intermittent Catheter (TPU Catheter)

Strait Access Technologies Holdings

SAT CenterFlow Molding Balloon Catheter (IN20-00313)

Asahi Intecc Co., Ltd.

Branchor X Balloon Guide Catheter

CenterPoint Systems, LLC

FlexiGo 3D Delivery Catheter

Bard Peripheral Vascular, Inc.

Dorado PTA Balloon Dilatation Catheter

Guangdong Ecan Medical Co., Ltd.

Silicone Urethral Catheter (Silicone Urethral Catheter)

Bioptimal International Pte. , Ltd.

Bioptimal Bipolar Pacing Catheter

Surgical Instrument Service and Savings, Inc.

Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

Olympus Medical Systems Corporation

Disposable Balloon Catheter B5-2C

Raptor Aspiration Catheter; Balt Aspiration Tubing Set

Becton Dickinson Infusion Therapy Systems, Inc.

BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector

W. L. Gore & Associates, Inc.

GORE® Tri-Lobe Balloon Catheter

Imperative Care, Inc.

Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing

Piraeus Medical

93 NeuFlex Catheter

ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach

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