Catalog Number

611230

Brand Name

COEfficient™

Version/Model Number

611230

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"

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

K014124

Product Code

MAD

Product Code Name

CATHETER, PERCUTANEOUS (VALVULOPLASTY)

Public Device Record Key

114e5708-612d-422a-b42e-402e8ac3fd0a

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-