Catalog Number

-

Brand Name

Axium Prime Detachable Coil System

Version/Model Number

APB-3.5-8-3D-ES

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K151447

Product Code

HCG

Product Code Name

DEVICE, NEUROVASCULAR EMBOLIZATION

Public Device Record Key

5c39c966-0917-407c-8adf-6337f7554e3d

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

August 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-