MedTekOSTry the sandbox

FDA Tracker

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

Live from openFDA. Refreshed daily. Free, no account, no rate limit. Drop any clearance into Compass as a predicate candidate when you have a tenant.

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

Reflow Medical, Inc.

Kiba CTO Crossing Catheter

Imperative Care, Inc.

Zoom 4S Catheter

Beijing Fule Science & Technology Development Co., Ltd.

Fule Vertebroplasty Balloon Catheter

Maquet Critical Care AB

Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)

Medtronic Ireland

NC Euphora Rapid Exchange Balloon Dilatation Catheter

CERENOVUS, Inc.

CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set

APRO 35 Swift Catheter

APRO 35 Swift Catheter and Alembic Aspiration Tubing

Spectrum Vascular

Unimpregnated Central Venous Catheter

Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).

Class Medical , Ltd.

Transurethral Catheter Safety Valve (TUCSV) (80050)

Teleflex Medical Sdn. Bhd.

Rusch Latex Gold Foley Catheter

Swift Sync, Inc.

Sync AV II Temporary Pacing Catheter

CenterPoint Systems, LLC

CPS Locator 3D Plus Delivery Catheter

CenterPoint Systems, LLC

SSPC NXT Delivery Catheter

Shockwave Medical, Inc.

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter

Medtronic Ireland

Euphora Rapid Exchange (RX) Balloon Dilatation Catheter

Luma Vision Limited

VERAFEYE Imaging Catheter (VF-VIC-002)

Scientia Vascular, Inc.

Socrates Aspiration System (Socrates 70 Aspiration Catheter)

Free Flow Medical, Inc.

LungFlow Airway Catheter

Millipede88 Access Catheter

MedSource Labs, LLC

MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV 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 Jimushi Meditech Co., Ltd.

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

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

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

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)

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

BARE Wireguided Balloon Dilation Catheter (1235)

Free Flow Medical, Inc.

LungFlow Basket Catheter

Liv Pre-lubricated Intermittent 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)

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)

Li Medical Corporation , Ltd.

RELIEEV HSG Catheter (HSG7FA1)

Surgical Instrument Service and Savings, Inc.

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

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

Centerpoint Systems

CPS Locator 3D Delivery Catheter

Cerenovus, Inc.

CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set

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

live · openFDA · refreshed daily

Want this dataset, AI-summarized?

Compass turns these into substantial-equivalence tables.

Pick three predicates from this list, paste their K-numbers into Compass, and get a draft SE comparison against your device in under a minute. The same RIG that powers the agent above.

Try the sandbox