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
Cleared
Apr 28, 2021
Plato 17 Microcatheter
Scientia Vascular, LLC
Neurology
58d
Cleared
Mar 31, 2021
Guidion
Imds Operations B.V.
Cardiovascular
71d
Cleared
Mar 03, 2021
FineCross M3
Ashitaka Factory of Terumo Corporation
Cardiovascular
92d
Cleared
Mar 01, 2021
Recon Support Catheter
C.R. Bard, Inc.
Cardiovascular
115d
Cleared
Feb 25, 2021
Phenom Catheters
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Neurology
28d
Cleared
Dec 14, 2020
Ventrax Delivery System
Merit Medical Systems, Inc.
Cardiovascular
96d
Cleared
Oct 26, 2020
coraForce and coraFlex Support Catheters
Reflow Medical, Inc.
Cardiovascular
117d
Cleared
Oct 16, 2020
Selectra 3D Outer Guiding Catheters
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),
Asahi Intecc Co., Ltd.
Cardiovascular
29d
Cleared
Aug 06, 2020
NHancer Rx
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
Medtronic, Inc.
Cardiovascular
311d
Cleared
Jul 21, 2020
BOBBY Balloon Guide Catheter
MicroVention, Inc.
Neurology
208d
Cleared
Jun 29, 2020
Twin-Pass Dual Access Catheter
Vascular Solutions, LLC
Cardiovascular
230d
Cleared
Jun 11, 2020
Benchmark BMX96 Access System
Penumbra, Inc.
Neurology
30d
Cleared
Jun 03, 2020
Agilis HisPro Steerable Catheter With Electrodes
Abbott (St. Jude Medical)
Cardiovascular
76d
Cleared
May 14, 2020
Support Catheter
Qxmedical, LLC
Cardiovascular
97d
Cleared
May 06, 2020
XO Cross Support Catheter
Transit Scientific
Cardiovascular
149d
Cleared
Apr 06, 2020
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
Mivi Neurovascular
Neurology
202d
Cleared
Apr 02, 2020
NovaCross CTO Microcatheter
Nitiloop , Ltd.
Cardiovascular
122d
Cleared
Mar 18, 2020
speX LP Support Catheter
Reflow Medical
Cardiovascular
62d
Cleared
Feb 20, 2020
Wingman 14, Wingman 14C, Wingman 18, Wingman 35
Reflow Medical
Cardiovascular
59d
Cleared
Feb 19, 2020
speX Support Catheter
Reflow Medical
Cardiovascular
113d
Cleared
Jan 21, 2020
TrapIt
Imds Operations B.V.
Cardiovascular
258d
Cleared
Jan 13, 2020
Route 92 Medical Sheath System
Route 92 Medical, Inc.
Neurology
201d