Who else makes this device?

Name: AxiumTM
Brand: AxiumTM

AxiumTM · Device, Neurovascular Embolization → Neurology

5manufacturers in China registered for this device type

89catalogue numbers in this listing

11510(k) clearances naming this product code

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 AxiumTM
Listed by	Micro Therapeutics, Inc., United States
FDA product code	HCG
Device type	Device, Neurovascular Embolization
Device class	Class 2
Regulation	21 CFR 882.5950
510(k)	K133310
Record published	2015-09-07
Record revised	2026-06-12 (version 6)

Specifications

Specifications
MRI safety	MR Conditional
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Storage	Special storage condition: Store in a dry cool place not to exceed 50 degrees Celsius
Distribution end date	2026-06-09

Catalogue Numbers

Catalogue numbers for AxiumTM
Catalogue number	Size	Status
PC-3-6-3D		In distribution
PC-2-2-3D		In distribution
QC-3.5-12-3D		In distribution
NC-2-2-HELIX		In distribution
QC-2.5-6-3D		In distribution
PC-3-4-HELIX		In distribution
QC-2-8-HELIX		In distribution
APB-2-3-HX-ES		In distribution
PC-3-8-3D		In distribution
PC-2-8-HELIX		In distribution
PC-2-1-HELIX		In distribution
QC-3-8-3D		In distribution
QC-3-4-3D		In distribution
QC-2-4-3D		In distribution
PC-2-3-HELIX		In distribution
PC-3-6-HELIX		In distribution
PC-2-6-HELIX		In distribution
PC-2-2-HELIX		In distribution
PC-2-6-3D		In distribution
QC-1.5-1-HELIX		Withdrawn
QC-9-20-HELIX		Withdrawn
QC-2.5-6-3D		Withdrawn
NC-2-1-HELIX		Withdrawn
FC-7-15-3D		Withdrawn
NC-2-4-HELIX		Withdrawn
QC-1.5-2-HELIX		Withdrawn
QC-3-10-3D		Withdrawn
NC-2-8-HELIX		Withdrawn
FC-20-50-3D		Withdrawn
FC-10-40-3D		Withdrawn
FC-12-50-3D		Withdrawn
APB-1-3-HX-ES		Withdrawn
QC-9-20-3D		Withdrawn
FC-5-20-3D		Withdrawn
NC-2-3-HELIX		Withdrawn
NC-3-6-HELIX		Withdrawn
NC-3-4-HELIX		Withdrawn
FC-6-10-3D		Withdrawn
QC-1.5-4-HELIX		Withdrawn
APB-1-2-HX-ES		Withdrawn
QC-3-8-HELIX		Withdrawn
APB-1-1-HX-ES		Withdrawn
FC-3-10-3D		Withdrawn
QC-2.5-8-3D		Withdrawn
QC-2.5-6-HELIX		Withdrawn
NC-2-2-HELIX		Withdrawn
FC-22-50-3D		Withdrawn
FC-6-15-3D		Withdrawn
QC-3.5-15-3D		Withdrawn
NC-2-8-HELIX		Withdrawn
QC-3.5-6-3D		Withdrawn
QC-3-6-3D		Withdrawn
NC-2-4-HELIX		Withdrawn
FC-18-50-3D		Withdrawn
QC-2.5-4-3D		Withdrawn
NC-2-6-HELIX		Withdrawn
QC-2.5-4-3D		Withdrawn
NC-4-10-HELIX		Withdrawn
FC-3.5-10-3D		Withdrawn
FC-3.5-6-3D		Withdrawn
QC-3.5-12-3D		Withdrawn
QC-1.5-3-HELIX		Withdrawn
FC-7-20-3D		Withdrawn
FC-7-12-3D		Withdrawn
NC-2-3-HELIX		Withdrawn
PC-3-4-3D		Withdrawn
QC-2.5-8-HELIX		Withdrawn
NC-3-8-HELIX		Withdrawn
QC-2.5-2-3D		Withdrawn
QC-2.5-2-HELIX		Withdrawn
QC-2.5-8-3D		Withdrawn
QC-12-30-3D		Withdrawn
FC-14-50-3D		Withdrawn
QC-9-30-3D		Withdrawn
NC-3-4-HELIX		Withdrawn
PC-8-30-HELIX		Withdrawn
NC-2-6-HELIX		Withdrawn
QC-1.5-3-HELIX		Withdrawn
QC-3.5-15-3D		Withdrawn
FC-12-40-3D		Withdrawn
FC-9-30-3D		Withdrawn
NC-2-1-HELIX		Withdrawn
FC-4-10-3D		Withdrawn
QC-2.5-2-HELIX		Withdrawn
QC-1.5-4-HELIX		Withdrawn
FC-5-10-3D		Withdrawn
FC-5-8-3D		Withdrawn
QC-2.5-4-HELIX		Withdrawn
QC-3-6-HELIX		Withdrawn

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
LP Coil System	Penumbra Inc.	77
Trufill DCS Orbit	Cerenovus, Inc.	74

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K060747	2007-04-24
K060625	2006-04-20
K051560	2005-06-28
K051425	2005-06-22
K050543	2005-04-27
K041649	2004-07-16
K040694	2004-03-25
K033372	2004-01-09
K032497	2003-09-25
K031852	2003-08-20
K030392	2003-07-21

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of AxiumTM
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Covidien	510(k) number	2010-03-01	Not classified	Employee error	ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.	13 units	2012-01-31
Covidien	510(k) number	2010-03-01	Not classified	Employee error	ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.	14 units	2012-01-31

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.

AxiumTM