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
97–120 of 895
Cleared Apr 28, 2021
Plato 17 Microcatheter
K210601
Scientia Vascular, LLC
Neurology · 58d
Cleared Mar 31, 2021
Guidion
K210110
Imds Operations B.V.
Cardiovascular · 71d
Cleared Mar 03, 2021
FineCross M3
K203521
Ashitaka Factory of Terumo Corporation
Cardiovascular · 92d
Cleared Mar 01, 2021
Recon Support Catheter
K203275
C.R. Bard, Inc.
Cardiovascular · 115d
Cleared Feb 25, 2021
Phenom Catheters
K210230
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Neurology · 28d
Cleared Dec 14, 2020
Ventrax Delivery System
K202610
Merit Medical Systems, Inc.
Cardiovascular · 96d
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