Catalog Number

-

Brand Name

LMI CAROTID ENDARTERECTOMY SHUNT CATHETER

Version/Model Number

12FCESB15

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

K983802

Product Code

MJN

Product Code Name

Catheter, Intravascular Occluding, Temporary

Public Device Record Key

806010ca-9eab-45b4-a4c2-08af79acc8e8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-