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
145–168 of 889
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
K183463
Stryker
Neurology · 89d
Cleared Dec 29, 2018
ViperCath XC Peripheral Exchange Catheter
K183000
Cardiovascular Systems, Inc.
Cardiovascular · 60d
Cleared Dec 20, 2018
ASAHI Corsair Pro XS
K182420
Asahi Intecc Co., Ltd.
Cardiovascular · 106d
Cleared Dec 14, 2018
Xcess Guiding Catheter
K180797
Curatia Medical Co.
Cardiovascular · 262d
Cleared Dec 13, 2018
Selectra Catheters, Selectra Accessory Kit
K183265
Biotronik, Inc.
Cardiovascular · 20d
Cleared Dec 10, 2018
Route 92 Medical Delivery Catheter
K182512
Route 92 Medical, Inc.
Neurology · 89d
Cleared Dec 07, 2018
Tractus Crossing Support Catheter
K180889
Tractus Vascular, LLC
Cardiovascular · 247d
Cleared Nov 14, 2018
React 71 Catheter
K182097
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 103d
Cleared Nov 09, 2018
Teleport Microcatheter
K182360
Orbusneich Medical Trading, Inc.
Cardiovascular · 71d
Cleared Oct 05, 2018
GORE Tri-Lumen Catheter
K180919
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
K181563
Access Scientific, LLC
Cardiovascular · 104d
Cleared Sep 13, 2018
SelectFlex 072 Neurovascular Access System
K181000
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
K180169
Imperative Care, Inc.
Neurology · 198d
Cleared Jul 20, 2018
WATCHMAN TruSeal Access System
K180864
Boston Scientific
Cardiovascular · 109d
Cleared Jul 04, 2018
React 68 Catheter
K180715
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Cardiovascular · 107d
Cleared Jun 11, 2018
Phenom 27 Catheter
K180959
Cathera, Inc.
Cardiovascular · 60d
Cleared May 23, 2018
Route 92 Medical Access System
K180201
Route 92 Medical, Inc.
Cardiovascular · 119d
Cleared May 15, 2018
XableCath Support Catheter Product Family
K180986
Xablecath, Inc.
Cardiovascular · 29d
Cleared Apr 18, 2018
Wingman 35 Crossing Catheter
K173661
Reflow Medical, Inc.
Cardiovascular · 140d
Cleared Apr 05, 2018
Wedge Microcatheter
K172014
MicroVention, Inc.
Cardiovascular · 276d
Cleared Apr 04, 2018
TrapLiner catheter
K180088
Vascular Solutions, Inc.
Cardiovascular · 82d
Cleared Mar 30, 2018
Merit Pursue Microcatheter
K173548
Merit Medical Systems, Inc.
Cardiovascular · 134d
Cleared Mar 29, 2018
NaviCross 0.018
K173799
Terumo Corporation
Cardiovascular · 105d
Cleared Jan 26, 2018
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
K173709
Inneuroco, Inc.
Cardiovascular · 53d