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
Cleared
Mar 13, 2019
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
Stryker
Neurology
89d
Cleared
Dec 29, 2018
ViperCath XC Peripheral Exchange Catheter
Cardiovascular Systems, Inc.
Cardiovascular
60d
Cleared
Dec 20, 2018
ASAHI Corsair Pro XS
Asahi Intecc Co., Ltd.
Cardiovascular
106d
Cleared
Dec 14, 2018
Xcess Guiding Catheter
Curatia Medical Co.
Cardiovascular
262d
Cleared
Dec 13, 2018
Selectra Catheters, Selectra Accessory Kit
Biotronik, Inc.
Cardiovascular
20d
Cleared
Dec 10, 2018
Route 92 Medical Delivery Catheter
Route 92 Medical, Inc.
Neurology
89d
Cleared
Dec 07, 2018
Tractus Crossing Support Catheter
Tractus Vascular, LLC
Cardiovascular
247d
Cleared
Nov 14, 2018
React 71 Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
103d
Cleared
Nov 09, 2018
Teleport Microcatheter
Orbusneich Medical Trading, Inc.
Cardiovascular
71d
Cleared
Oct 05, 2018
GORE Tri-Lumen Catheter
W. L. Gore and Associates, Inc.
Cardiovascular
179d
Cleared
Sep 26, 2018
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
Access Scientific, LLC
Cardiovascular
104d
Cleared
Sep 13, 2018
SelectFlex 072 Neurovascular Access System
Q'Apel
Neurology
150d
Cleared
Aug 08, 2018
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length
Imperative Care, Inc.
Neurology
198d
Cleared
Jul 20, 2018
WATCHMAN TruSeal Access System
Boston Scientific
Cardiovascular
109d
Cleared
Jul 04, 2018
React 68 Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Cardiovascular
107d
Cleared
Jun 11, 2018
Phenom 27 Catheter
Cathera, Inc.
Cardiovascular
60d
Cleared
May 23, 2018
Route 92 Medical Access System
Route 92 Medical, Inc.
Cardiovascular
119d
Cleared
May 15, 2018
XableCath Support Catheter Product Family
Xablecath, Inc.
Cardiovascular
29d
Cleared
Apr 18, 2018
Wingman 35 Crossing Catheter
Reflow Medical, Inc.
Cardiovascular
140d
Cleared
Apr 05, 2018
Wedge Microcatheter
MicroVention, Inc.
Cardiovascular
276d
Cleared
Apr 04, 2018
TrapLiner catheter
Vascular Solutions, Inc.
Cardiovascular
82d
Cleared
Mar 30, 2018
Merit Pursue Microcatheter
Merit Medical Systems, Inc.
Cardiovascular
134d
Cleared
Mar 29, 2018
NaviCross 0.018
Terumo Corporation
Cardiovascular
105d
Cleared
Jan 26, 2018
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
Inneuroco, Inc.
Cardiovascular
53d