Catalog Number

-

Brand Name

CAROTID ENDARTERECTOMY SHUNT

Version/Model Number

12FCES15

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

087ae437-e03e-4407-957e-f09ccdb68b07

Public Version Date

July 30, 2019

Public Version Number

1

DI Record Publish Date

July 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-