Catalog Number

-

Brand Name

Axiom® Femoral Venous

Version/Model Number

100280

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

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

K842084,K842084,K842084

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

df6145dd-6d94-476b-89e1-cb03bdd4372b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M6651002803

Quantity per Package

6

Contains DI Package

M6651002801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case