Who else makes this device?

Name: Glidewire Advantage Track
Brand: Glidewire Advantage Track

Glidewire Advantage Track · Wire, Guide, Catheter → Cardiovascular

10manufacturers in China registered for this device type

4catalogue numbers in this listing

15510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DQX
Manufacturer	City	Province	Registered as	Device types
Mehow Innovative (Huizhou) Ltd.	Huizhou	Guangdong	Contract manufacturer	11
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Suzhou Prosteri Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Sunny Medical Device (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	11
Lepu Medical Technology (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	7
Beijing Target Medical Technologies Inc.	Beijing	Beijing	Contract manufacturer	7
Suzhou Zenith Vascular Scitech Limited	Suzhou	Jiangsu	Manufacturer	6
Beijing Bywave Sensing Medical Technology Co., Ltd.	Beijing	Beijing	Manufacturer	2
Shanghai Achieva Medical Suzhou Co., Ltd.	Suzhou	Jiangsu	Manufacturer	2
Deepintec Scientific Co., Ltd.	Beijing	Beijing	Manufacturer	2

Record

Regulatory record for Glidewire Advantage Track
Listed by	Terumo Corp., Japan
FDA product code	DQX
Device type	Wire, Guide, Catheter
Device class	Class 2
Regulation	21 CFR 870.1330
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2019-11-20

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Fragile,handle with care. Keep dry. Keep away from sunlight. Stacking limit by 9.
Packaging	Carton of 10
Sizes	Length 180 to 300 cm; outer diameter 0.36 to 0.46 mm

Catalogue Numbers

Catalogue numbers for Glidewire Advantage Track
Catalogue number	Size	Status
GAT1418	Distal flexible length; 1 centimeters	In distribution
GAT1818	Distal flexible length; 1 centimeters	In distribution
GAT1430	Outer Diameter 0.36 mm	In distribution
GAT1830	Length 300 cm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Arrow	Teleflex Medical LLC	625
Cook	Cook Incorporated	410
Guidewire	Argon Medical Devices, Inc.	173
Medline Industries, Inc.	Medline Industries, Inc.	151
Guidewire	Galt Medical Corp.	144
Amplatz	Cook Incorporated	128
InQwire®	Merit Medical Systems, Inc.	120
Angiographic Guide Wire	Medtronic, Inc.	94
Glidewire	Terumo Corp.	83
Starter™ Guidewire	Lake Region Medical Limited	82
INT,Falcon Guide Wire	Shanghai Kindly Medical Instruments Co., Ltd.	72
GuideRight™	St. Jude Medical	69

Showing 12 of 525. All products under Wire, Guide, Catheter

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K240818	2024-11-26
K240859	2024-08-21
K170417	2017-09-15
K122590	2013-03-01
K080563	2008-03-20
K063695	2007-04-27
K063372	2007-01-19
K961445	1996-07-09
K955801	1996-02-02
K953533	1995-10-18
K925852	1993-06-10
K924202	1992-11-23
K913074	1991-11-05
K910969	1991-05-16
K863138	1986-11-20

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2011-06-03	Not classified	Device Design	Baloon catheter guidewires may become uncoiled during angioplasty procedures.	70 units	2011-07-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Glidewire Advantage Track