Who else makes this device?

Name: Axius Coronary Shunt
Brand: Axius Coronary Shunt

Axius Coronary Shunt · Clamp, Vascular → Cardiovascular

10manufacturers in China registered for this device type

12catalogue numbers in this listing

4recalls on this code

Who Else Makes It

Concentrated in Beijing (3), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DXC
Manufacturer	City	Province	Registered as	Device types
Suzhou Meccan Import and Export Corp.	Suzhou	Jiangsu	Contract manufacturer	71
Shanghai INT Medical Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	10
Tianjin Demax Medical Technology Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	5
Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd.	Huizhou	Guangdong	Contract manufacturer	3
Joykey Industrial (Pinghu) Limited	Pinghu	Zhejiang	Contract manufacturer	43
Sunny Medical Device (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	11
Lepu Medical Technology (Beijing) Co., Ltd.	Beijing	Beijing	Manufacturer	7
Terumo Medical Products (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	7
Beijing Target Medical Technologies Inc.	Beijing	Beijing	Contract manufacturer	7
Beijing Demax Medical Technology Co., Ltd.	Beijing	Beijing	Manufacturer	5

Record

Regulatory record for Axius Coronary Shunt
Listed by	Maquet Cardiovascular LLC, United States
FDA product code	DXC
Device type	Clamp, Vascular
Device class	Class 2
Regulation	21 CFR 870.4450
Establishment	Specification developer, Manufacturer
510(k)	K010117
Record published	2016-09-24
Record revised	2025-02-06 (version 5)

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
Packaging	5 pack box of 5
Sizes	Outer diameter 1 to 3.5 mm

Catalogue Numbers

Catalogue numbers for Axius Coronary Shunt
Catalogue number	Size	Status
OF-1500	Outer Diameter 1.50 mm	In distribution
OF-1000	Outer Diameter 1.0 mm	In distribution
OF-2500	Outer Diameter 2.5 mm	In distribution
OF-2000L	Outer Diameter 2.0 mm	In distribution
OF-1250	Outer Diameter 1.25 mm	In distribution
OF-1500L	Outer Diameter 1.5 mm	In distribution
OF-1750	Outer Diameter 1.75 mm	In distribution
OF-2250	Outer Diameter 2.25 mm	In distribution
OF-2000	Outer Diameter 2.0 mm	In distribution
OF-3500	Outer Diameter 3.5 mm	In distribution
OF-3000	Outer Diameter 3.0 mm	In distribution
OF-2750	Outer Diameter 2.75 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Millennium	Avalign Technologies, Inc.	831
Novo Surgical	Novo Surgical, Inc.	708
Ambler Surgical	Ambler Surgical, LLC	575
Pilling	Teleflex Medical LLC	544
Avalign	Avalign Technologies, Inc.	543
Boss Instruments	Boss Instruments, Ltd.	457
V. Mueller	Steris Corporation	432
Wexler Surgical, Inc.	Wexler Surgical, Inc.	342
Integra® Jarit®	Integra LifeSciences Production Corporation	331
Scanlan®	Scanlan International, Inc.	294
HNM Medical	HNM Stainless, LLC.	230
Aesculap	Aesculap AG	136

Showing 12 of 639. All products under Clamp, Vascular

Recalls

3 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
2025-08-15	Class II	Under Investigation by firm	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.	12,471 units (6,565 US, 5,906 OUS)
2025-08-15	Class II	Under Investigation by firm	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.	126 units (91 US, 35 OUS)
2025-08-15	Class II	Under Investigation by firm	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.	28,331 units (16,615 US, 11,716 OUS)
2010-05-05	Not classified	Process design	Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.	1630	2011-06-21

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.

Axius Coronary Shunt