Catalog Number

105041

Brand Name

AngioJet® XMI®

Version/Model Number

105041-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

P980037,P980037,P980037,P980037,P980037,P980037,P980037,P980037

Product Code

MCX

Product Code Name

CATHETER, CORONARY, ATHERECTOMY

Public Device Record Key

cbc10e1b-1fab-43b0-9bc5-ecfffc99af24

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

April 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-