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, Cordis Corp. and C.R. Bard, Inc..

889
Total
889
Cleared
104d
Avg days
1979
Since
889 devices
97–120 of 889
Cleared Oct 26, 2020
coraForce and coraFlex Support Catheters
K201811
Reflow Medical, Inc.
Cardiovascular · 117d
Cleared Oct 16, 2020
Selectra 3D Outer Guiding Catheters
K193474
Biotronik, Inc.
Cardiovascular · 305d
Cleared Sep 08, 2020
ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),
K202252
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Aug 06, 2020
NHancer Rx
K200324
Imds Operations B.V.
Cardiovascular · 178d
Cleared Aug 03, 2020
Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter
K192712
Medtronic, Inc.
Cardiovascular · 311d
Cleared Jul 21, 2020
BOBBY Balloon Guide Catheter
K193607
MicroVention, Inc.
Neurology · 208d
Cleared Jun 29, 2020
Twin-Pass Dual Access Catheter
K193119
Vascular Solutions, LLC
Cardiovascular · 230d
Cleared Jun 11, 2020
Benchmark BMX96 Access System
K201271
Penumbra, Inc.
Neurology · 30d
Cleared Jun 03, 2020
Agilis HisPro Steerable Catheter With Electrodes
K200721
Abbott (St. Jude Medical)
Cardiovascular · 76d
Cleared May 14, 2020
Support Catheter
K200317
Qxmedical, LLC
Cardiovascular · 97d
Cleared May 06, 2020
XO Cross Support Catheter
K193420
Transit Scientific
Cardiovascular · 149d
Cleared Apr 06, 2020
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
K192558
Mivi Neurovascular
Neurology · 202d
Cleared Apr 02, 2020
NovaCross CTO Microcatheter
K193322
Nitiloop , Ltd.
Cardiovascular · 122d
Cleared Mar 18, 2020
speX LP Support Catheter
K200094
Reflow Medical
Cardiovascular · 62d
Cleared Feb 20, 2020
Wingman 14, Wingman 14C, Wingman 18, Wingman 35
K193596
Reflow Medical
Cardiovascular · 59d
Cleared Feb 19, 2020
speX Support Catheter
K193012
Reflow Medical
Cardiovascular · 113d
Cleared Jan 21, 2020
TrapIt
K191229
Imds Operations B.V.
Cardiovascular · 258d
Cleared Jan 13, 2020
Route 92 Medical Sheath System
K191717
Route 92 Medical, Inc.
Neurology · 201d
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