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..

893
Total
893
Cleared
104d
Avg days
1979
Since
893 devices
433–456 of 893
Cleared Mar 11, 1997
VISTA BRITE TIP CATHETERS
K965211
Cordis Corp.
Cardiovascular · 74d
Cleared Oct 17, 1996
VISTA BRITE TIP CATHETERS
K962830
Cordis Corp.
Cardiovascular · 87d
Cleared Aug 08, 1996
CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS
K962362
Cordis Corp.
Cardiovascular · 50d
Cleared May 15, 1996
SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
K961280
Scimed Life Systems, Inc.
Cardiovascular · 42d
Cleared Jan 16, 1996
SCIMED ANGIOGRAPHIC KITS
K953265
Scimed Life Systems, Inc.
Cardiovascular · 187d
Cleared Dec 07, 1995
ACS TOURGIDE GUIDING CATHETER
K953987
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 106d
Cleared Oct 23, 1995
5F ENVOY GUIDING CATHETER (MODIFICATION)
K954251
Cordis Neurovascular, Inc.
Cardiovascular · 60d
Cleared Sep 25, 1995
FASGUIDE
K951159
Target Therapeutics
Cardiovascular · 195d
Cleared Sep 19, 1995
SCIMED TRIGUIDE GUIDE CATHETERS
K953515
Scimed Life Systems, Inc.
Cardiovascular · 55d
Cleared Aug 17, 1995
MEDI-TECH PLATFORM GUIDE CATHETER
K952345
Medi-Tech, Inc.
Cardiovascular · 90d
Cleared Aug 04, 1995
ACS POWERBASE GUILDING CATHETER
K952205
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 86d
Cleared Aug 02, 1995
CORDIS BRITE TIP, ENVOY GUIDING CATHETER
K952185
Cordis Corp.
Cardiovascular · 85d
Cleared Mar 13, 1995
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS
K946204
Scimed Life Systems, Inc.
Cardiovascular · 82d
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