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, Biotronik, Inc. and Cordis Corp..

895
Total
895
Cleared
104d
Avg days
1979
Since
Stable submission activity - 36 submissions in the last 2 years
Consistent review times: 106d avg (recent)

FDA 510(k) Cleared Catheter, Percutaneous Devices (Product Code DQY)

895 devices
1–24 of 895
Cleared Aug 14, 2026
NHanceIT
K260559
IMDS Operation B.V.
Cardiovascular · 176d
Cleared Aug 12, 2026
APRO 35 Swift Catheter
K262392
Alembic, LLC
Neurology · 29d
Cleared Jul 29, 2026
CPS Locator 3D Plus Delivery Catheter
K261766
CenterPoint Systems, LLC
Cardiovascular · 62d
Cleared Jul 29, 2026
SSPC NXT Delivery Catheter
K262240
CenterPoint Systems, LLC
Cardiovascular · 28d
Cleared Jul 02, 2026
Amplatzer TorqVue LP Delivery System
K261825
Abbott
Cardiovascular · 30d
Cleared Jun 17, 2026
Amplatzer TorqVue Exchange System
K261631
Abbott Medical
Cardiovascular · 30d
Cleared Jun 05, 2026
Perfect-O Ostial Positioning Catheter
K260289
Balosmark, Inc.
Cardiovascular · 127d
Cleared Apr 24, 2026
Amplatzer TorqVue Delivery System
K260993
Abbott
Cardiovascular · 29d
Cleared Apr 10, 2026
Teleport Glide Microcatheter
K253361
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 192d
Cleared Mar 13, 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499
Abbott Medical
Cardiovascular · 28d
Cleared Dec 19, 2025
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409
Medtronic, Inc.
Cardiovascular · 80d
Cleared Dec 17, 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417
Abbott Medical
Cardiovascular · 138d
Cleared Oct 29, 2025
Telescope Guide Extension Catheter
K252390
Medtronic, Ireland
Cardiovascular · 90d
Cleared Aug 22, 2025
CPS Locator 3D Delivery Catheter
K250147
Centerpoint Systems
Cardiovascular · 213d
Cleared Aug 22, 2025
CoraForce Microcatheter, CoraFlex Microcatheter
K251277
Reflow Medical, Inc.
Cardiovascular · 120d
Cleared Jun 29, 2025
Primum Hydrophilic Guiding Catheter
K250972
Pendracare
Cardiovascular · 90d
Cleared Jun 27, 2025
CPS Locator 3D Plus Delivery Catheter
K250828
CenterPoint Systems, LLC
Cardiovascular · 100d
Cleared Jun 25, 2025
SAT CenterFlow Molding Balloon Catheter (IN20-00313)
K243184
Strait Access Technologies Holdings
Cardiovascular · 268d
Cleared Jun 18, 2025
FlexiGo 3D Delivery Catheter
K250492
CenterPoint Systems, LLC
Cardiovascular · 118d
Cleared Jun 17, 2025
Dorado™ PTA Balloon Dilatation Catheter
K250219
Bard Peripheral Vascular, Inc.
Cardiovascular · 144d
Cleared Jun 02, 2025
GORE® Tri-Lobe Balloon Catheter
K250410
W.L. Gore & Associates, Inc.
Cardiovascular · 109d
Cleared May 02, 2025
Shockwave CS Guide Catheter
K243757
Shockwave Medical, Inc.
Cardiovascular · 147d
Cleared May 01, 2025
APRO 45 Catheter
K251014
Alembic, LLC
Neurology · 29d
Cleared Apr 29, 2025
APRO 55 Intermediate Catheter
K250962
Alembic, LLC
Neurology · 29d

About Product Code DQY - Regulatory Context

510(k) Submission Activity

895 total 510(k) submissions under product code DQY since 1979, with 895 receiving FDA clearance (average review time: 104 days).

Submission volume has remained relatively stable over the observed period, with 36 submissions in the last 24 months.

FDA 510(k) Review Time - DQY Product Code

FDA review times for DQY submissions have been consistent, averaging 106 days recently vs 104 days historically.

DQY devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →