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
601–624 of 766
Cleared Nov 01, 1989
DATASCOPE STEERING HANDLE
K894940
Datascope Corp.
Cardiovascular · 90d
Cleared Oct 17, 1989
CORDIS STEERABLE COATED GUIDEWIRE
K894633
Cordis Corp.
Cardiovascular · 85d
Cleared Oct 12, 1989
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K894318
Datascope Corp.
Cardiovascular · 90d
Cleared Sep 26, 1989
FLEXMEDICS GUIDEWIRE
K893626
Flexmedics
Cardiovascular · 138d
Cleared Aug 17, 1989
USCI PROBE LINX EXTENSION WIRE
K890404
C.R. Bard, Inc.
Cardiovascular · 205d
Cleared Jun 20, 1989
USCI GREY/BLACK GUIDE WIRE
K890505
C.R. Bard, Inc.
Cardiovascular · 139d
Cleared Jun 20, 1989
GUIDE WIRE INTRODUCER
K890807
Datascope Corp.
Cardiovascular · 124d
Cleared May 31, 1989
INTERVENTIONAL PRODUCTS - GUIDE WIRES
K890207
E-Z-Em, Inc.
Cardiovascular · 134d
Cleared Apr 06, 1989
KATZEN THROMBOLYSIS GUIDEWIRE
K883880
Medi-Tech, Inc.
Cardiovascular · 205d
Cleared Mar 31, 1989
ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.
K882507
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 287d
Cleared Feb 06, 1989
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
K884895
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 76d
Cleared Jan 17, 1989
INTRODUCER SAFETY SYRINGE
K884490
Arrow Intl., Inc.
Cardiovascular · 83d
Cleared Jan 12, 1989
USCI ADJUSTABLE TIP GUIDE WIRE
K884647
C.R. Bard, Inc.
Cardiovascular · 66d
Cleared Dec 27, 1988
BUCHBINDER MULTIFLEX GUIDEWIRE
K884274
Medtronic Vascular
Cardiovascular · 76d
Cleared Dec 21, 1988
ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE
K884262
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Dec 13, 1988
TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE
K884198
Target Therapeutics
Cardiovascular · 68d
Cleared Nov 04, 1988
CORONARY GUIDE WIRE
K883579
Datascope Corp.
Cardiovascular · 74d
Cleared Sep 27, 1988
TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE
K882928
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 81d
Cleared Aug 30, 1988
ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT
K882321
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Aug 19, 1988
COATING FOR WIRE GUIDE
K880722
Cook, Inc.
Cardiovascular · 178d
Cleared Aug 19, 1988
TAPER-22 STEERABLE GUIDEWIRE
K880761
Target Therapeutics
Cardiovascular · 176d
Cleared Aug 19, 1988
TAPER FLEX-TIP STEERABLE GUIDEWIRE
K880762
Target Therapeutics
Cardiovascular · 176d
Cleared Aug 03, 1988
ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
K881897
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 89d
Cleared Jul 28, 1988
MEDRAD OPEN ENDED GUIDEWIRE
K880332
Medrad, Inc.
Cardiovascular · 184d