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
649–672 of 895
Cleared Jan 14, 1994
9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
K934988
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 11, 1994
ACS POWERGUIDE CORONARY GUIDING CATHETER
K934009
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 146d
Cleared Sep 28, 1993
USCI SUPER 6 6F PTCA GUIDING CATHETER
K933019
C.R. Bard, Inc.
Cardiovascular · 98d
Cleared Sep 24, 1993
MICROSNARE
K925439
Microvena Corp.
Cardiovascular · 331d
Cleared Sep 10, 1993
GUIDING CATHETER HEMOSTASIS VALVE CAP
K933033
Arrow Intl., Inc.
Cardiovascular · 80d
Cleared Aug 24, 1993
TRANSSEPTAL INTRODUCER SET
K932619
Thomas Medical Products, Inc.
Cardiovascular · 84d
Cleared May 06, 1993
CORDIS 9 F GUIDING CATHETER
K925131
Cordis Corp.
Cardiovascular · 205d
Cleared Apr 30, 1993
ITC CATHETERS W/ HYDROMER
K922609
Interventional Therapeutics Corp.
Cardiovascular · 332d
Cleared Mar 23, 1993
ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH
K926421
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Feb 12, 1993
TRIGUIDE-PLUS GUIDING CATHETER
K923245
Scimed Life Systems, Inc.
Cardiovascular · 225d
Cleared Jan 12, 1993
GUIDING CATHETER
K923518
Interventional Therapeutics Corp.
Cardiovascular · 182d
Cleared Jan 11, 1993
SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER
K922611
Scimed Life Systems, Inc.
Cardiovascular · 223d
Cleared Dec 08, 1992
SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER
K924591
Schneider Intl., Ltd.
Cardiovascular · 89d
Cleared Sep 09, 1992
CORDIS SHUTTLE CATHETER W/ SIDEHOLES
K921311
Cordis Corp.
Cardiovascular · 175d
Cleared May 20, 1992
E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION
K914984
E-Z-Em, Inc.
Cardiovascular · 210d
Cleared May 01, 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856
Cook, Inc.
Cardiovascular · 185d
Cleared Apr 22, 1992
RIGHT ATRIAL CATHETER KITS
K920331
Akcess Medical Products, Inc.
Cardiovascular · 90d
Cleared Mar 23, 1992
TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED
K915521
Target Therapeutics
Cardiovascular · 144d
Cleared Feb 14, 1992
CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER
K915374
Cordis Corp.
Cardiovascular · 77d
Cleared Feb 11, 1992
CORDIS SHUTTLE CATHETER
K915777
Cordis Corp.
Cardiovascular · 49d
Cleared Nov 22, 1991
ITC GUIDING CATHETER
K913052
Interventional Therapeutics Corp.
Cardiovascular · 136d
Cleared Nov 22, 1991
SCIMED 8 FR. TRIGUIDEFLEX GUIDING CATHETERS
K913830
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Nov 05, 1991
ISOLATE INFUSION CATHETR SYSTEM
K913517
Lake Region Mfg., Inc.
Cardiovascular · 90d
Cleared Oct 18, 1991
CORDIS PTCA GUIDING CATHETER, MODIFICATION
K913783
Dow Corning Wright
Cardiovascular · 65d