Avenir

Embolic Coil

Registry build 21.09.26
5manufacturers in China registered for this device type
69catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HCG
Manufacturer City Province Registered as Device types
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
Shanghai Wallaby Medical Technologies Co., Inc. Shanghai Shanghai Contract manufacturer 5
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Suzhou Prosteri Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 20
Microport Neurotech (Shanghai) Co., Ltd. Shanghai Shanghai Manufacturer 2

Record

Regulatory record for Avenir
Listed by Shanghai Wallaby Medical Technologies Co., Inc., China
FDA product code HCG
Device type Device, Neurovascular Embolization
Device class Class 2
Regulation 21 CFR 882.5950
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
Record published 2022-07-29
Record revised 2024-03-25 (version 5)

Specifications

Specifications
MRI safety MR Conditional
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Avenir
Catalogue number Size Status
10USH03504 In distribution
10USC05008 In distribution
10USH01504 In distribution
10USH03006 In distribution
10USH02001 In distribution
10USC05010 In distribution
10USH01502 In distribution
10USH05006 In distribution
10CSW03030 In distribution
10USH01002 In distribution
10USC01003 In distribution
10CFR07024 In distribution
10USH04008 In distribution
10USC01001 In distribution
10USH02506 In distribution
10USH01503 In distribution
10USH01501 In distribution
10USC04008 In distribution
10USC02506 In distribution
10USC03004 In distribution
10USC04510 In distribution
10USC02006 In distribution
10USC01503 In distribution
10USC03504 In distribution
10CSW03020 In distribution
10USC01502 In distribution
10USC03506 In distribution
10USH02004 In distribution
10USH04010 In distribution
10USC04508 In distribution
10USC02505 In distribution
10CSW02012 In distribution
10USH01001 In distribution
10USH03506 In distribution
10USH02502 In distribution
10USH02006 In distribution
10USH04006 In distribution
10USH03508 In distribution
10USC01004 In distribution
10USC03508 In distribution
10USC04010 In distribution
10USC02002 In distribution
10USC0101H In distribution
10USH03008 In distribution
10USH02504 In distribution
10USH01004 In distribution
10USC03008 In distribution
10USC05006 In distribution
10USH05008 In distribution
10USC02003 In distribution
10USC02503 In distribution
10USH02503 In distribution
10USH02002 In distribution
10USC04506 In distribution
10USC04006 In distribution
10CSW04040 In distribution
10USH05010 In distribution
10CSW04030 In distribution
10USC0102H In distribution
10CSW02020 In distribution
10USC0152H In distribution
10USH03004 In distribution
10USH01003 In distribution
10USC03006 In distribution
10USC01002 In distribution
10USC01504 In distribution
10USH02003 In distribution
10USC02504 In distribution
10USC02004 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Optima Coil System Balt USA, LLC 307
Penumbra Coil 400 Penumbra Inc. 268
Smart Coil Penumbra Inc. 238
Axium™ Detachable Coil System Micro Therapeutics, Inc. 234
Numen Microport Neurotech (Shanghai) Co., Ltd. 223
Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. 141
Barricade Coil System Balt USA, LLC 137
Numen Helia Microport Neurotech (Shanghai) Co., Ltd. 129
V-Trak MicroVention, Inc. 106
HydroSoft Helical MicroVention, Inc. 94
AxiumTM Micro Therapeutics, Inc. 89
LP Coil System Penumbra Inc. 77

Showing 12 of 99. All products under Device, Neurovascular Embolization

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer