Catalog Number

-

Brand Name

Jade PTA Balloon Dilatation Catheter

Version/Model Number

606008032

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K202231

Product Code

LIT

Product Code Name

Catheter, Angioplasty, Peripheral, Transluminal

Public Device Record Key

f2cc4e9a-8312-4847-bb73-ac0ec43434d8

Public Version Date

January 04, 2021

Public Version Number

1

DI Record Publish Date

December 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-