Who else makes this device?

Name: Stedi™
Brand: Stedi™

Stedi™ · Wire, Guide, Catheter → Cardiovascular

10manufacturers in China registered for this device type

2catalogue numbers in this listing

6510(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 Stedi™
Listed by	Medtronic, Inc., United States
FDA product code	DQX
Device type	Wire, Guide, Catheter
Device class	Class 2
Regulation	21 CFR 870.1330
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K250075
Record published	2025-07-18

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number
Storage	Special storage condition: Keep away from sunlight
Sizes	Length 275 cm; outer diameter 0.035 in

Catalogue Numbers

Catalogue numbers for Stedi™
Catalogue number	Size	Per pack	Status
STEDI-4	Length 275.0 cm	5	In distribution
STEDI-3	Curve 3 CM	5	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
K250075	2025-06-13
K143316	2015-03-11
K140695	2014-06-12
K132623	2013-12-19
K101339	2010-08-31
K100470	2010-04-21

Recalls

2 of these are 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
2013-03-13	Class II	Component change control	Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified	27,682 devices	2014-02-06
2013-03-13	Class II	Mixed-up of materials/components	Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.	225 units	2013-11-21

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.

Stedi™