Catalog Number

-

Brand Name

Selethru PTCA Balloon Dilatation Catheter

Version/Model Number

KPTCA400010

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"

-

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

K182699

Product Code

LOX

Product Code Name

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Public Device Record Key

0e3de988-07dd-4afb-9100-6a917f60cfe3

Public Version Date

May 25, 2020

Public Version Number

1

DI Record Publish Date

May 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-