Catalog Number

IAA-03722

Brand Name

ARROW

Version/Model Number

IPN000225

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K060309

Product Code

DSP

Product Code Name

System, balloon, intra-aortic and control

Public Device Record Key

c6d8d14f-bc00-432c-98d8-5d2257dfbd65

Public Version Date

June 10, 2020

Public Version Number

5

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-