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 Abbott Medical, CenterPoint Systems, LLC and OrbusNeich Medical (Shenzhen) Co., Ltd..
888
Total
888
Cleared
104d
Avg days
1979
Since
888 devices
Cleared
Dec 31, 2024
MitraClip™ G5 Steerable Guide Catheter (SGC0801)
Abbott Medical
Cardiovascular
85d
Cleared
Dec 20, 2024
SENDERO MAX Delivery Catheter
Okami Medical, Inc.
Cardiovascular
108d
Cleared
Dec 19, 2024
Shadow Catheter
Simpson Interventions, Inc.
Cardiovascular
262d
Cleared
Dec 04, 2024
SSPC NXT Delivery Catheter
CenterPoint Systems, LLC
Cardiovascular
65d
Cleared
Sep 30, 2024
CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
Vantis Vascular, Inc.
Cardiovascular
60d
Cleared
Sep 12, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
Biotronik, Inc.
Cardiovascular
174d
Cleared
Sep 03, 2024
ShapeIT (SI014135)
Imds Operations B.V.
Cardiovascular
90d
Cleared
Aug 26, 2024
TriClip Steerable Guide Catheter
Abbott Medical
Cardiovascular
88d
Cleared
Jun 28, 2024
Cordis BRITECROSS Support Catheter
Cordis US Corp
Cardiovascular
228d
Cleared
Jun 25, 2024
ASAHI Veloute
Asahi Intecc Co., Ltd.
Cardiovascular
60d
Cleared
May 28, 2024
React 71 Catheter
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Neurology
29d
Cleared
Mar 15, 2024
APRO 55 Catheter
Alembic, LLC
Neurology
79d
Cleared
Mar 08, 2024
SENDERO Microcatheter
Okami Medical, Inc.
Cardiovascular
29d
Cleared
Feb 08, 2024
SINC Support Catheter
Reflow Medical, Inc.
Cardiovascular
132d
Cleared
Feb 01, 2024
WATCHMAN TruSteer Access System (M635TU90050)
Boston Scientific Corporation
Cardiovascular
30d
Cleared
Jan 07, 2024
Teleport XT Microcatheter
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular
219d
Cleared
Sep 29, 2023
Amulet™ Steerable Delivery Sheath
Abbott Medical
Cardiovascular
28d
Cleared
Aug 30, 2023
Ventrax™ Delivery System (VTR851)
Merit Medical Systems, Inc.
Cardiovascular
121d
Cleared
Aug 22, 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
Medtronic Vascular
Cardiovascular
29d
Cleared
Aug 08, 2023
Rubicon™ Control Support Catheter (H749394323506A1)
Boston Scientific Corporation
Cardiovascular
246d
Cleared
Jul 27, 2023
R2P Navicross
Terumo Medical Corporation
Cardiovascular
106d
Cleared
Jun 30, 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
Medtronic Vascular
Cardiovascular
162d
Cleared
Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
Abbott Medical
Cardiovascular
28d
Cleared
May 25, 2023
Stingray LP Catheter
Boston Scientific
Cardiovascular
30d