DQX · Class II · 21 CFR 870.1330

FDA Product Code DQX: Wire, Guide, Catheter

FDA product code DQX covers catheter guidewires used in intravascular procedures.

These thin, flexible wires are inserted into blood vessels to guide catheters, sheaths, and other devices to their target location. They are available in a wide range of diameters, stiffness profiles, and tip shapes optimized for different anatomical access points and clinical applications.

DQX devices are Class II medical devices, regulated under 21 CFR 870.1330 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Asahi Intecc Co., Ltd., Advanced Cardiovascular Systems, Inc. and Lake Region Mfg., Inc..

766
Total
766
Cleared
116d
Avg days
1976
Since
766 devices
481–504 of 766
Cleared Jun 05, 1995
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
K945379
Boston Scientific Corp
Cardiovascular · 215d
Cleared Jun 02, 1995
NAVIGUIDE HYDROPHILIC GUIDE WIRE
K943358
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 325d
Cleared May 25, 1995
SCIMED CHOICE PT PTCA GUIDE WIRE
K950835
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared May 15, 1995
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
K950752
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d
Cleared Apr 28, 1995
PRECEDER GUIDEWIRE
K950352
Boston Scientific Corp
Cardiovascular · 88d
Cleared Apr 28, 1995
SCIMED SCEPTOR PTCA GUIDE WIRE
K950534
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Apr 28, 1995
SCIMED SCEPTOR EXCHANGE GUIDE WIRE
K950535
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Apr 14, 1995
SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE
K950266
Scimed Life Systems, Inc.
Cardiovascular · 81d
Cleared Apr 14, 1995
CORDIS STEERABLE GUIDEWIRES
K950316
Cordis Corp.
Cardiovascular · 78d
Cleared Apr 12, 1995
DASHER-14
K950069
Target Therapeutics
Cardiovascular · 93d
Cleared Apr 05, 1995
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE
K950156
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d
Cleared Mar 31, 1995
SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE
K946240
Scimed Life Systems, Inc.
Cardiovascular · 99d
Cleared Mar 31, 1995
M-PATH NITINOL GUIDEWIRE
K946356
Microvena Corp.
Cardiovascular · 91d
Cleared Mar 31, 1995
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE
K950113
Scimed Life Systems, Inc.
Cardiovascular · 79d
Cleared Mar 31, 1995
SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE
K950141
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Mar 17, 1995
SCIMED(R) ENTRE PTCA GUIDE WIRE
K946180
Scimed Life Systems, Inc.
Cardiovascular · 87d
Cleared Mar 03, 1995
SCIMED CHIOCE PLUS PTCA GUIDE WIRE
K945129
Scimed Life Systems, Inc.
Cardiovascular · 135d
Cleared Feb 24, 1995
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
K946029
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 77d
Cleared Dec 30, 1994
SCIMED PURSUIT EXCHANGE PTCA GUIDE WIRE
K945159
Scimed Life Systems, Inc.
Cardiovascular · 70d
Cleared Dec 19, 1994
THE PROMPT GUIDWIRE
K943522
Cordis Corp.
Cardiovascular · 154d
Cleared Dec 08, 1994
GUIDE WIRE
K942453
Boston Scientific Corp
Cardiovascular · 199d
Cleared Sep 19, 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE
K943022
Cardio Metrics, Inc.
Cardiovascular · 87d
Cleared Sep 16, 1994
CORDIS STEERABLE GUIDEWIRE
K943340
Cordis Corp.
Cardiovascular · 66d
Cleared Aug 31, 1994
SCIMED EN TRE' III PTCA GUIDE WIRE
K942333
Scimed Life Systems, Inc.
Cardiovascular · 107d