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
193–216 of 895
Cleared Jun 07, 2017
Venture 038 catheter
K171335
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared May 31, 2017
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
K171268
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Cardiovascular · 30d
Cleared Apr 06, 2017
MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter
K163233
Mivi Neuroscience, Inc.
Cardiovascular · 140d
Cleared Mar 23, 2017
Guidezilla II Guide Extension Catheter
K163314
Boston Scientific Corporation
Cardiovascular · 120d
Cleared Mar 07, 2017
CenterCross Ultra LV Catheter
K170403
Roxwood Medical, Inc.
Cardiovascular · 26d
Cleared Feb 18, 2017
VIA 17 Microcatheter
K162565
Sequent Medical, Inc.
Cardiovascular · 157d
Cleared Feb 03, 2017
TrapLiner catheter
K161901
Vascular Solutions, Inc.
Cardiovascular · 207d
Cleared Feb 01, 2017
Twin-Pass Torque
K162467
Vascular Solutions, Inc.
Cardiovascular · 152d
Cleared Jan 06, 2017
Trapper Exchange Device
K162253
Creganna Medical Aslo Business AS Cregganna Tactx Medical
Cardiovascular · 149d
Cleared Jan 05, 2017
YOGA Microcatheter
K162563
Codman & Shurtleff, Inc.
Cardiovascular · 113d
Cleared Dec 23, 2016
AMPLATZER TorqVue 45x45 Delivery Sheath
K163000
Aga Medical COrporation (Wholly Owned by St. Jude Medical CO
Cardiovascular · 56d
Cleared Nov 02, 2016
Boosting Catheter
K160561
Qxmedical, LLC
Cardiovascular · 247d
Cleared Oct 14, 2016
R2P SlenGuide
K161546
Ashitaka Factory of Terumo Corporation
Cardiovascular · 133d
Cleared Oct 12, 2016
Navien Intracranial Support Catheter
K161152
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Cardiovascular · 170d
Cleared Sep 22, 2016
TrailBlazer Angled Support Catheter
K162384
Medtronic Vascular, Inc.(Formerly Ev3 Inc.)
Cardiovascular · 28d
Cleared Sep 21, 2016
Surefire Guiding Catheter
K162359
Surefire Medical, Inc.
Cardiovascular · 29d
Cleared Sep 19, 2016
Super Distal Access (SDA)
K161262
Inneuroco, Inc.
Cardiovascular · 137d
Cleared Sep 09, 2016
TorqVue Low Profile Delivery Catheter
K162228
Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor
Cardiovascular · 32d
Cleared Aug 25, 2016
ASAHI Corsair Pro
K161126
Asahi Intecc Co., Ltd.
Cardiovascular · 126d
Cleared Aug 04, 2016
SIDEKICK and USHER Support Catheters
K161986
Bard Peripheral Vascular, Inc.
Cardiovascular · 16d
Cleared Jul 14, 2016
Wingman 18 Crossing Catheter
K160848
Reflow Medical, Inc.
Cardiovascular · 108d
Cleared Jul 12, 2016
ARTLINE
K160448
Health Line International Corporation
Cardiovascular · 145d
Cleared Jun 17, 2016
CenterCross Ultra Catheter
K160681
Roxwood Medical, Inc.
Cardiovascular · 99d
Cleared Jun 14, 2016
ASAHI Corsair Armet
K161362
Asahi Intecc Co., Ltd.
Cardiovascular · 29d