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
73–96 of 889
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 Apr 11, 2022
XO CROSS CORONARY Support Catheter
K214107
Transit Scientific, LLC
Cardiovascular · 103d
Cleared Mar 09, 2022
Amplatzer Steerable Delivery Sheath
K220340
Abbott Medical
Cardiovascular · 30d
Cleared Feb 09, 2022
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
K212211
Vascular Solutions, LLC
Cardiovascular · 209d
Cleared Jan 28, 2022
QuikPass Catheter
K214106
Traverse Vascular, Inc.
Cardiovascular · 30d
Cleared Nov 24, 2021
Guiding Catheter
K210009
CenterPoint Systems, LLC
Cardiovascular · 324d
Cleared Oct 21, 2021
XO Cross Support Catheter
K210322
Transit Scientific, LLC
Cardiovascular · 259d
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 Jul 15, 2021
ReCross
K210431
Imds Operations B.V.
Cardiovascular · 153d
Cleared Jul 07, 2021
Arterial Catheter
K201726
Haolang Medical USA Corporation
Cardiovascular · 379d
Cleared May 28, 2021
coraCross
K210188
Reflow Medical
Cardiovascular · 123d
Cleared May 26, 2021
ViperCath XC Peripheral Exchange Catheter
K211251
Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Apr 30, 2021
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter
K210647
Vascular Solutions, LLC
Cardiovascular · 58d
Cleared Apr 28, 2021
Plato 17 Microcatheter
K210601
Scientia Vascular, LLC
Neurology · 58d
Cleared Mar 31, 2021
Guidion
K210110
Imds Operations B.V.
Cardiovascular · 71d
Cleared Mar 03, 2021
FineCross M3
K203521
Ashitaka Factory of Terumo Corporation
Cardiovascular · 92d
Cleared Mar 01, 2021
Recon Support Catheter
K203275
C.R. Bard, Inc.
Cardiovascular · 115d
Cleared Feb 25, 2021
Phenom Catheters
K210230
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Neurology · 28d
Cleared Dec 14, 2020
Ventrax Delivery System
K202610
Merit Medical Systems, Inc.
Cardiovascular · 96d