Catalog Number

BTK-14-38150

Brand Name

ARROW

Version/Model Number

IPN001027

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

K142300,K142300

Product Code

LIT

Product Code Name

Catheter, angioplasty, peripheral, transluminal

Public Device Record Key

67018887-b69a-40a7-8993-51723ad3303f

Public Version Date

December 19, 2019

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

30801902083662

Quantity per Package

1

Contains DI Package

00801902083661

Package Discontinue Date

December 18, 2019

Package Status

Not in Commercial Distribution

Package Type

Box