DQY · Class II · 21 CFR 870.1250

FDA Product Code DQY: Catheter, Percutaneous

Percutaneous catheters are foundational tools in interventional cardiology and vascular medicine. FDA product code DQY covers catheters designed for percutaneous access to the vascular system.

These devices enable clinicians to navigate blood vessels to deliver therapies, measure pressures, or access cardiac structures without open surgery. They are used in angioplasty, electrophysiology, structural heart procedures, and hemodynamic monitoring.

DQY devices are Class II medical devices, regulated under 21 CFR 870.1250 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Medtronic Vascular, Biotronik, Inc. and Cordis Corp..

895
Total
895
Cleared
104d
Avg days
1979
Since
895 devices
121–144 of 895
Cleared Jan 07, 2020
BioCardia 8F Morph DNA Deflectable Guide Catheter
K192774
Biocardia
Cardiovascular · 99d
Cleared Dec 24, 2019
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
K192135
MicroVention, Inc.
Neurology · 139d
Cleared Dec 23, 2019
RIST Cath Radial Access Long Sheath
K191551
Rist Neurovascular, Inc.
Neurology · 194d
Cleared Dec 15, 2019
AXS Vecta Aspiration Catheter
K190833
Stryker Neurovascular
Neurology · 258d
Cleared Dec 12, 2019
Lumax Guiding Catheter
K191163
Cook Incorporated
Cardiovascular · 225d
Cleared Nov 29, 2019
ASAHI CROSSWALK Peripheral Support Catheter
K192782
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Nov 29, 2019
AXS Infinity LS Plus Long Sheath
K193034
Stryker Neurovascular
Neurology · 29d
Cleared Nov 21, 2019
PG Pro Microcatheter
K192625
MicroVention, Inc. A TERUMO Group Company
Cardiovascular · 59d
Cleared Nov 21, 2019
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool
K192996
Biotronik, Inc.
Cardiovascular · 24d
Cleared Nov 08, 2019
CERENOVUS Large Bore Catheter
K191237
Codman & Shurtleff, Inc.
Neurology · 184d
Cleared Oct 31, 2019
087 Balloon Guide Catheter System
K192525
Q'Apel Medical, LLC
Neurology · 48d
Cleared Sep 20, 2019
Medtronic 6F Taiga Guiding Catheter
K192296
Medtronic Vascular
Cardiovascular · 28d
Cleared Aug 30, 2019
SelectFlex 072 Neurovascular Access System
K191664
Q'Apel Medical
Neurology · 70d
Cleared Aug 09, 2019
Turnpike Catheter
K191560
Vascular Solutions, LLC
Cardiovascular · 57d
Cleared Aug 05, 2019
Crossing Support Catheter
K183305
Tractus Vascular, LLC
Cardiovascular · 250d
Cleared Jul 20, 2019
CerusEndo Microcatheter
K182487
Cerus Endovascular, Inc.
Neurology · 312d
Cleared Jul 15, 2019
087 Balloon Guide Catheter System
K190749
Q'Apel
Neurology · 112d
Cleared Jul 10, 2019
Scepter Mini Occlusion Balloon Catheter
K182829
MicroVention, Inc.
Neurology · 278d
Cleared Jun 28, 2019
Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4
K190475
Centerpoint Systems
Cardiovascular · 121d
Cleared Jun 22, 2019
ASAHI SASUKE
K182844
Asahi Intecc Co., Ltd.
Cardiovascular · 256d
Cleared May 23, 2019
Upstream GoBack Crossing Catheter
K182937
Upstream Peripheral Technologies, Ltd.
Cardiovascular · 213d
Cleared May 15, 2019
SOFIA EX Intracranial Support Catheter
K182602
MicroVention, Inc.
Neurology · 236d
Cleared May 09, 2019
Wingman 14C Crossing Catheter
K190393
Reflow Medical, Inc.
Cardiovascular · 79d
Cleared Apr 05, 2019
Amplatzer Trevisio Intravascular Delivery System
K190581
Abbott Medical
Cardiovascular · 30d