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 Abbott Medical, CenterPoint Systems, LLC and OrbusNeich Medical (Shenzhen) Co., Ltd..

888
Total
888
Cleared
104d
Avg days
1979
Since
888 devices
25–48 of 888
Cleared Dec 31, 2024
MitraClip™ G5 Steerable Guide Catheter (SGC0801)
K243224
Abbott Medical
Cardiovascular · 85d
Cleared Dec 20, 2024
SENDERO MAX Delivery Catheter
K242644
Okami Medical, Inc.
Cardiovascular · 108d
Cleared Dec 19, 2024
Shadow Catheter
K240885
Simpson Interventions, Inc.
Cardiovascular · 262d
Cleared Dec 04, 2024
SSPC NXT Delivery Catheter
K243180
CenterPoint Systems, LLC
Cardiovascular · 65d
Cleared Sep 30, 2024
CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
K242276
Vantis Vascular, Inc.
Cardiovascular · 60d
Cleared Sep 12, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
K240787
Biotronik, Inc.
Cardiovascular · 174d
Cleared Sep 03, 2024
ShapeIT (SI014135)
K241611
Imds Operations B.V.
Cardiovascular · 90d
Cleared Aug 26, 2024
TriClip Steerable Guide Catheter
K241538
Abbott Medical
Cardiovascular · 88d
Cleared Jun 28, 2024
Cordis BRITECROSS Support Catheter
K233637
Cordis US Corp
Cardiovascular · 228d
Cleared Jun 25, 2024
ASAHI Veloute
K241158
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared May 28, 2024
React 71 Catheter
K241177
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Neurology · 29d
Cleared Mar 15, 2024
APRO 55 Catheter
K234115
Alembic, LLC
Neurology · 79d
Cleared Mar 08, 2024
SENDERO Microcatheter
K240384
Okami Medical, Inc.
Cardiovascular · 29d
Cleared Feb 08, 2024
SINC Support Catheter
K233350
Reflow Medical, Inc.
Cardiovascular · 132d
Cleared Feb 01, 2024
WATCHMAN TruSteer Access System (M635TU90050)
K240018
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jan 07, 2024
Teleport XT Microcatheter
K231608
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 219d
Cleared Sep 29, 2023
Amulet™ Steerable Delivery Sheath
K232690
Abbott Medical
Cardiovascular · 28d
Cleared Aug 30, 2023
Ventrax™ Delivery System (VTR851)
K231246
Merit Medical Systems, Inc.
Cardiovascular · 121d
Cleared Aug 22, 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190
Medtronic Vascular
Cardiovascular · 29d
Cleared Aug 08, 2023
Rubicon™ Control Support Catheter (H749394323506A1)
K223633
Boston Scientific Corporation
Cardiovascular · 246d
Cleared Jul 27, 2023
R2P Navicross
K231044
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
K230156
Medtronic Vascular
Cardiovascular · 162d
Cleared Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
K231311
Abbott Medical
Cardiovascular · 28d
Cleared May 25, 2023
Stingray LP Catheter
K231176
Boston Scientific
Cardiovascular · 30d