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
625–648 of 895
Cleared Jul 25, 1995
MEDTRONIC(R) GC III CORONARY GUIDING CATHETER
K950179
Medtronics Interventional Vascular
Cardiovascular · 189d
Cleared Apr 05, 1995
MEDTRONIC(R) 8.2 FRENCH SHERPA(R) SUPER PEAK FLOW(TM) CORONARY GUIDING CATHETER
K950026
Medtronics Interventional Vascular
Cardiovascular · 91d
Cleared Mar 13, 1995
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS
K946204
Scimed Life Systems, Inc.
Cardiovascular · 82d
Cleared Mar 03, 1995
SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS
K944668
Medtronics Interventional Vascular
Cardiovascular · 171d
Cleared Mar 03, 1995
SCIMED 6 FRENCH MICRO-MAX(TM) GUIDE CATHETER
K950094
Scimed Life Systems, Inc.
Cardiovascular · 52d
Cleared Mar 01, 1995
CANDELA SHEATH SETS
K950634
Candela Laser Corp.
Cardiovascular · 16d
Cleared Mar 01, 1995
CANDEKA DUKATIR SETS
K950635
Candela Laser Corp.
Cardiovascular · 16d
Cleared Feb 03, 1995
5F ENVOY(TM) GUIDING CATHETER
K945705
Cordis Neurovascular, Inc.
Cardiovascular · 87d
Cleared Nov 30, 1994
SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER
K943622
Boston Scientific Scimed, Inc.
Cardiovascular · 126d
Cleared Oct 21, 1994
SCIMED TRIGUIDE GUIDE CATHETER
K944537
Scimed Life Systems, Inc.
Cardiovascular · 36d
Cleared Oct 18, 1994
FASGUIDE CATHETER
K935597
Target Therapeutics
Cardiovascular · 333d
Cleared Oct 13, 1994
SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER
K943777
Scimed Life Systems, Inc.
Cardiovascular · 72d
Cleared Oct 13, 1994
7 FRENCH LARGE LUMEN TRIGUIDE-PLUS
K943783
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Jun 22, 1994
SCIMED TRIGUIDE GUIDING CATHETER
K941137
Scimed Life Systems, Inc.
Cardiovascular · 104d
Cleared Jun 10, 1994
SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER
K935292
Boston Scientific Scimed, Inc.
Cardiovascular · 220d
Cleared May 06, 1994
SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH
K940545
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared May 04, 1994
MEDTRONIC GCIII CORONARY GUIDING CATHETER
K935738
Medtronics Interventional Vascular
Cardiovascular · 154d
Cleared May 03, 1994
ACS POWERBASE(TM) CORONARY GUIDING CATHETER
K940559
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Apr 26, 1994
METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS
K935425
Medtronics Interventional Vascular
Cardiovascular · 167d
Cleared Apr 19, 1994
SCIMED 8 FRENCH TRIGUIDE GUIDING CATHETER
K940603
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Apr 07, 1994
SOFTTOUCH GUIDE CATHETER
K934685
Mallinckrodt Medical
Cardiovascular · 189d
Cleared Mar 30, 1994
ENVOY GUIDING CATHETER
K940187
Cordis Neurovascular, Inc.
Cardiovascular · 76d
Cleared Feb 10, 1994
GUIDING CATHETER
K930476
Boston Scientific Corp
Cardiovascular · 377d
Cleared Feb 01, 1994
GC IV CORONARY GUIDING CATHETER
K932933
Medtronics Interventional Vascular
Cardiovascular · 230d