Catalog Number

-

Brand Name

Inoue Balloon Catheter

Version/Model Number

PTMC-26

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MAD

Product Code Name

Catheter, Percutaneous (Valvuloplasty)

Public Device Record Key

8483822f-1b76-4cfe-8d27-73048866d8df

Public Version Date

November 30, 2021

Public Version Number

3

DI Record Publish Date

September 17, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-