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
895 devices
217–240 of 895
Cleared May 12, 2016
Guiding Catheter
K153703
Texasmedical Technologies, Inc.
Cardiovascular · 141d
Cleared Mar 11, 2016
NovaCross Microcatheter
K160389
Nitiloop , Ltd.
Cardiovascular · 29d
Cleared Mar 04, 2016
ASAHI Corsair Armet
K152249
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 04, 2016
MultiCross Catheter
K152957
Roxwood Medical, Inc.
Cardiovascular · 149d
Cleared Jan 27, 2016
8F FlowGate2 Balloon Guide Catheter
K153729
Concentric Medical
Cardiovascular · 30d
Cleared Jan 26, 2016
CenterCross Ultra Catheter
K152456
Roxwood Medical, Inc.
Cardiovascular · 151d
Cleared Jan 22, 2016
ASAHI Caravel
K152447
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
K152876
Tni Manufacturing, Inc.
Cardiovascular · 100d
Cleared Dec 14, 2015
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm
K152202
Tni Manufacturing, Inc.
Cardiovascular · 130d
Cleared Dec 09, 2015
MIVI Mi-AXUS Guide Catheter
K151396
Mivi Neuroscience, Inc.
Cardiovascular · 197d
Cleared Dec 07, 2015
Houdini Catheter
K151896
Cruzar Medsystems, Inc.
Cardiovascular · 150d
Cleared Dec 04, 2015
Stingray LP Catheter
K152401
Boston Scientific Corporation
Cardiovascular · 101d
Cleared Dec 02, 2015
Lantern Delivery Microcatheter
K152840
Penumbra, Inc.
Cardiovascular · 64d
Cleared Nov 13, 2015
Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
K151638
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
K151667
Stryker
Cardiovascular · 147d
Cleared Oct 23, 2015
ER-REBOA Catheter
K151821
Pryor Medical Devices, Inc.
Cardiovascular · 109d
Cleared Aug 28, 2015
VIA 21 Microcatheter
K150894
Sequent Medical, Inc.
Cardiovascular · 148d
Cleared Aug 13, 2015
Turnpike catheter
K151981
Vascular Solution, Inc.
Cardiovascular · 27d
Cleared Aug 07, 2015
Selectra Catheters and Selectra Accessory Kit
K151409
Biotronik, Inc.
Cardiovascular · 73d
Cleared Aug 07, 2015
Wingman Crossing Catheter
K151880
Reflow Medical
Cardiovascular · 29d
Cleared Aug 03, 2015
Metacross RX PTA Balloon Dilitation Catheter
K150865
KANEKA Corporation
Cardiovascular · 124d
Cleared Jul 29, 2015
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
K150107
Micro Therapeutics Inc Dba Ev3 Neurovascular
Cardiovascular · 190d
Cleared Jun 23, 2015
ASAHI Corsair Microcatheter
K151103
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared Jun 07, 2015
MicroCross Catheter
K151082
Roxwood Medical, Inc.
Cardiovascular · 46d