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
265–288 of 895
Cleared Mar 26, 2014
TOTAL ACROSS
K133539
Medtronic Vascular
Cardiovascular · 128d
Cleared Feb 26, 2014
SUREFIRE GUIDING CATHETER
K140034
Surefire Medical, Inc.
Cardiovascular · 50d
Cleared Feb 25, 2014
MODIFIED HD GUIDE CATHETER
K133177
Concentric Medical, Inc.
Cardiovascular · 131d
Cleared Feb 25, 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501
Vascular Solutions, Inc.
Cardiovascular · 103d
Cleared Jan 31, 2014
ENLIGHTN RENAL GUIDE CATHETER
K131592
St. Jude Medical, Inc.
Cardiovascular · 242d
Cleared Jan 29, 2014
ADVANCE CS CORONARY SINUS INFUSION CATHETER
K131204
Cook, Inc.
Cardiovascular · 275d
Cleared Dec 31, 2013
UNBALLOON NON-OCCLUSION MODELING CATHETER
K133026
LeMaitre Vascular, Inc.
Cardiovascular · 96d
Cleared Dec 20, 2013
VIA MICROCATHETER, VIA PLUS MICROCATHETER
K132652
Sequent Medical, Inc.
Cardiovascular · 116d
Cleared Nov 22, 2013
SOFIA DISTAL ACCESS CATHETER
K131482
MicroVention, Inc.
Cardiovascular · 183d
Cleared Nov 15, 2013
TRANSGATE GUIDE CATHETER
K132542
Stryker Neurovascular
Cardiovascular · 94d
Cleared Nov 01, 2013
SILK ROAD ACCESS CATHETER
K130649
Silk Road Medical, Inc.
Cardiovascular · 235d
Cleared Oct 24, 2013
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
K132556
Asahi Intecc Co., Ltd.
Cardiovascular · 71d
Cleared Oct 22, 2013
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
K132673
Medtronic, Inc.
Cardiovascular · 56d
Cleared Oct 17, 2013
RESPIGUIDE DELIVERY SYSTEM
K130378
Respicardia
Cardiovascular · 245d
Cleared Oct 11, 2013
REVERSE MEDICAL MICROCATHETER
K130858
Reverse Medical Corporation
Cardiovascular · 197d
Cleared Oct 03, 2013
OCCLUSION PERFUSION CATHETER
K130525
Advanced Catheter Therapies, Inc.
Cardiovascular · 217d
Cleared Oct 03, 2013
MODIFIED FLOWGATE BALLOON GUIDE CATHETER
K131492
Concentric Medical, Inc.
Cardiovascular · 133d
Cleared Sep 27, 2013
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
K132659
Volcano Corporation
Cardiovascular · 32d
Cleared Sep 26, 2013
PRIMI SUPPORT CATHETER
K132701
Thermopeutix, Inc.
Cardiovascular · 28d
Cleared Sep 19, 2013
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K132420
Reflow Medical
Cardiovascular · 45d
Cleared Aug 29, 2013
CONCIERGE GUIDING CATHETER
K132409
Merit Medical Systems, Inc.
Cardiovascular · 27d
Cleared Aug 23, 2013
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
K131978
Biotronik, Inc.
Cardiovascular · 56d
Cleared Aug 22, 2013
PROGIGY SUPPORT CATHETER
K130714
Radius Medical, LLC
Cardiovascular · 160d
Cleared Aug 15, 2013
AMPLATZER TORQ VUE LP DELIVERY SYSTEM
K131063
St Jude Medical
Cardiovascular · 121d