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
49–72 of 889
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 Jul 13, 2023
Micro Rx
K223728
Imds Operations B.V.
Cardiovascular · 212d
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
Cleared Apr 06, 2023
RayFlow
K222023
Hexacath
Cardiovascular · 269d
Cleared Mar 09, 2023
CPS Locator 3D Delivery Catheter
K230363
CenterPoint Systems, LLC
Cardiovascular · 27d
Cleared Mar 02, 2023
6F Wallaby Long Sheath
K222603
Wallaby Medical, Inc.
Neurology · 185d
Cleared Jan 10, 2023
ISAAC Neurovascular Navigation Catheter
K222115
MicroVention, Inc.
Neurology · 176d
Cleared Nov 08, 2022
SelectSite C304 Deflectable Catheter System, C315 Delivery System
K223178
Medtronic
Cardiovascular · 28d
Cleared Nov 07, 2022
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
K222873
Medtronic
Cardiovascular · 46d
Cleared Oct 20, 2022
Houdini Cross Support Catheter
K213466
Cruzar Medsystems, Inc.
Cardiovascular · 357d
Cleared Oct 14, 2022
Sublime Microcatheter
K221886
Surmodics,Inc.
Cardiovascular · 107d
Cleared Sep 12, 2022
SOFIA 88 Catheter
K214024
MicroVention, Inc.
Neurology · 264d
Cleared Aug 18, 2022
GuideLiner Coast, 5.5F (5270)
K220647
Vascular Solutions, LLC
Cardiovascular · 164d
Cleared Jul 29, 2022
091 Balloon Guide Catheter
K220331
Inneuroco, Inc.
Neurology · 175d
Cleared Jul 19, 2022
Selectra Lead Implantation System
K222037
Biotronik, Inc.
Cardiovascular · 8d
Cleared Jul 11, 2022
Artix Ballon Guiding Sheath
K221846
Inari Medical
Cardiovascular · 17d
Cleared Jun 30, 2022
CPS AIM Universal II Slittable Inner Catheter
K221750
Abbott Medical
Cardiovascular · 14d
Cleared Jun 02, 2022
Boss Crossing Support Catheter
K220632
Marvao Medical Devices, Ltd.
Cardiovascular · 90d
Cleared May 05, 2022
LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension
K220691
Seigla Medical, Inc.
Cardiovascular · 57d
Cleared May 05, 2022
Spartan SC 069
K220716
Spartan Micro, Inc.
Neurology · 55d