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 Vascular Solutions, Inc..

895
Total
895
Cleared
104d
Avg days
1979
Since
895 devices
457–480 of 895
Cleared Dec 16, 2005
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX
K053118
Boston Scientific Corp
Cardiovascular · 39d
Cleared Dec 13, 2005
VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER
K052258
Vascular Solutions, Inc.
Cardiovascular · 116d
Cleared Nov 23, 2005
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
K052257
Vascular Solutions, Inc.
Cardiovascular · 97d
Cleared Oct 31, 2005
VP SHEATH
K051580
Flowcardia, Inc.
Cardiovascular · 138d
Cleared Sep 26, 2005
ASAHI TORNUS SUPPORT CATHETER
K051772
Asahi Intecc Co., Ltd.
Cardiovascular · 88d
Cleared Sep 02, 2005
EDWARDS PERIPHERAL DILATION CATHETER
K052149
Edwards Lifesciences, LLC
Cardiovascular · 25d
Cleared Sep 01, 2005
MODIFIED CONCENTRIC RETRIEVER, MODEL 90039
K051838
Concentric Medical, Inc.
Cardiovascular · 56d
Cleared Aug 25, 2005
ATB ADVANCE PTA DILATATION CATHETER
K052036
Cook, Inc.
Cardiovascular · 28d
Cleared Aug 23, 2005
BARD ATLAS PTA BALLOON DILATATION CATHETER
K052236
Bard Peripheral Vascular, Inc.
Cardiovascular · 6d
Cleared Aug 05, 2005
7F SHERPA NX GUIDE CATHETER
K051846
Medtronic Vascular
Cardiovascular · 29d
Cleared Jul 28, 2005
MINI GHOST PTA CATHETER, MODEL 507
K051343
NuMED, Inc.
Cardiovascular · 66d
Cleared Jun 03, 2005
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
K050599
Boston Scientific Corp
Cardiovascular · 86d
Cleared May 26, 2005
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
K051060
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared May 25, 2005
ULTRA-SOFT SV BALLOON DILATATION CATHETER
K050389
Boston Scientific Corp
Cardiovascular · 99d
Cleared May 19, 2005
ENPATH DEFLECTABLE CATHETER
K043489
Enpath Medical Incorporated
Cardiovascular · 153d
Cleared Apr 13, 2005
RELIANT STENT GRAFT BALLOON CATHETER
K050038
Medtronic Endovascular Innovations
Cardiovascular · 96d
Cleared Mar 24, 2005
ALLIGATOR RETRIEVAL DEVICE (ARD)
K043580
Chestnut Medical Technologies, Inc.
Cardiovascular · 86d
Cleared Feb 17, 2005
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
K042553
Biocardia, Inc.
Cardiovascular · 150d
Cleared Feb 16, 2005
VASCON POLARIS GUIDING CATHETER
K043387
Vascon, LLC
Cardiovascular · 69d
Cleared Feb 11, 2005
MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K050073
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 30d
Cleared Jan 21, 2005
MODIFICATION TO OUTBACK CATHETER
K043534
Lumend, Inc.
Cardiovascular · 30d
Cleared Jan 10, 2005
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K042624
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 105d
Cleared Jan 07, 2005
PROXIS SYSTEM, MODEL EPS 101
K042117
Velocimed, Inc.
Cardiovascular · 155d
Cleared Dec 28, 2004
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
K042381
Acumen Medical, Inc.
Cardiovascular · 118d