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, Alembic, LLC and Cardiovascular Systems, Inc..

888
Total
888
Cleared
104d
Avg days
1979
Since
888 devices
49–72 of 888
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 Sep 12, 2022
SOFIA 88 Catheter
K214024
MicroVention, Inc.
Neurology · 264d
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 May 04, 2022
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
K212588
C.R. Bard, Inc.
Cardiovascular · 261d
Cleared Mar 09, 2022
Amplatzer Steerable Delivery Sheath
K220340
Abbott Medical
Cardiovascular · 30d
Cleared Sep 27, 2021
Amplatzer Steerable Delivery Sheath
K212026
Abbott Medical
Cardiovascular · 90d
Cleared Sep 27, 2021
Amplatzer Talisman Delivery Sheath
K212738
Abbott Medical
Cardiovascular · 28d
Cleared Sep 24, 2021
ViperCross Support Catheters
K212725
Cardiovascular Systems, Inc.
Cardiovascular · 28d
Cleared Aug 26, 2021
ViperCross Support Catheters
K211240
Cardiovascular Systems, Inc.
Cardiovascular · 122d
Cleared Aug 13, 2021
WATCHMAN FXD Curve Access System
K212228
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jul 27, 2021
Rist 071 Radial Access Guide Catheter
K211990
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 29d
Cleared May 26, 2021
ViperCath XC Peripheral Exchange Catheter
K211251
Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Mar 01, 2021
Recon Support Catheter
K203275
C.R. Bard, Inc.
Cardiovascular · 115d