Who else makes this device?

Name: FloWire Doppler Guide Wire XT 300cm 014 Jtip
Brand: FloWire Doppler Guide Wire XT 300cm 014 Jtip

Cardiovascular › DiagnosticWire, Guide, Catheter

FloWire Doppler Guide Wire XT 300cm 014 Jtip

Catalogue number 1413J, listed by Volcano Corporation, United States, under Wire, Guide, Catheter. 10 manufacturers in China are registered for this product code.

Registry build 21.09.26

10manufacturers in China registered for this device type

1catalogue number

7510(k) clearances naming this product code

2recalls on this code

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 FloWire Doppler Guide Wire XT 300cm 014 Jtip
Listed by	Volcano Corporation, United States
FDA product code	DQX
Device type	Wire, Guide, Catheter
Device class	Class 2
Regulation	21 CFR 870.1330
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K972762
Record published	2016-08-24
Record revised	2021-10-26 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	expiry date, serial number

Catalogue Numbers

Catalogue numbers for FloWire Doppler Guide Wire XT 300cm 014 Jtip
Catalogue number	Size	Status
1413J		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
K210235	2021-04-15
K202543	2020-09-28
K192886	2020-03-26
K161887	2016-09-20
K131288	2013-06-21
K111395	2011-08-01
K100930	2010-04-30

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of FloWire Doppler Guide Wire XT 300cm 014 Jtip
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Volcano Corporation	510(k) number	2009-10-06	Not classified	Employee error	Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.	14 in US; 42 to EU and 15 to Japan	2012-02-01

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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
2015-06-04	Class II	Labeling mix-ups	During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture	162 total (both devices)	2015-10-27

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.