Catalog Number

-

Brand Name

LMI ARTERIAL EMBOLECTOMY CATHETER

Version/Model Number

NL5EMB80T

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"

Yes

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

K954760

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

8b184a9b-3cfa-4c18-85d3-1c4646d9a264

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

October 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-