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
895 devices
Cleared
May 12, 2016
Guiding Catheter
Texasmedical Technologies, Inc.
Cardiovascular
141d
Cleared
Mar 11, 2016
NovaCross Microcatheter
Nitiloop , Ltd.
Cardiovascular
29d
Cleared
Mar 04, 2016
ASAHI Corsair Armet
Asahi Intecc Co., Ltd.
Cardiovascular
207d
Cleared
Mar 04, 2016
MultiCross Catheter
Roxwood Medical, Inc.
Cardiovascular
149d
Cleared
Jan 27, 2016
8F FlowGate2 Balloon Guide Catheter
Concentric Medical
Cardiovascular
30d
Cleared
Jan 26, 2016
CenterCross Ultra Catheter
Roxwood Medical, Inc.
Cardiovascular
151d
Cleared
Jan 22, 2016
ASAHI Caravel
Asahi Intecc Co., Ltd.
Cardiovascular
148d
Cleared
Jan 08, 2016
LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
Tni Manufacturing, Inc.
Cardiovascular
100d
Cleared
Dec 14, 2015
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm
Tni Manufacturing, Inc.
Cardiovascular
130d
Cleared
Dec 09, 2015
MIVI Mi-AXUS Guide Catheter
Mivi Neuroscience, Inc.
Cardiovascular
197d
Cleared
Dec 07, 2015
Houdini Catheter
Cruzar Medsystems, Inc.
Cardiovascular
150d
Cleared
Dec 04, 2015
Stingray LP Catheter
Boston Scientific Corporation
Cardiovascular
101d
Cleared
Dec 02, 2015
Lantern Delivery Microcatheter
Penumbra, Inc.
Cardiovascular
64d
Cleared
Nov 13, 2015
Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
Cathera, Inc.
Cardiovascular
149d
Cleared
Nov 13, 2015
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm
Stryker
Cardiovascular
147d
Cleared
Oct 23, 2015
ER-REBOA Catheter
Pryor Medical Devices, Inc.
Cardiovascular
109d
Cleared
Aug 28, 2015
VIA 21 Microcatheter
Sequent Medical, Inc.
Cardiovascular
148d
Cleared
Aug 13, 2015
Turnpike catheter
Vascular Solution, Inc.
Cardiovascular
27d
Cleared
Aug 07, 2015
Selectra Catheters and Selectra Accessory Kit
Biotronik, Inc.
Cardiovascular
73d
Cleared
Aug 07, 2015
Wingman Crossing Catheter
Reflow Medical
Cardiovascular
29d
Cleared
Aug 03, 2015
Metacross RX PTA Balloon Dilitation Catheter
KANEKA Corporation
Cardiovascular
124d
Cleared
Jul 29, 2015
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
Micro Therapeutics Inc Dba Ev3 Neurovascular
Cardiovascular
190d
Cleared
Jun 23, 2015
ASAHI Corsair Microcatheter
Asahi Intecc Co., Ltd.
Cardiovascular
60d
Cleared
Jun 07, 2015
MicroCross Catheter
Roxwood Medical, Inc.
Cardiovascular
46d