Catalog Number

PP0710

Brand Name

Cardion™

Version/Model Number

PP0710

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K191734

Product Code

PSQ

Product Code Name

Intracardiac patch or pledget, biologically derived

Public Device Record Key

6bcd5d2b-f9cc-4f6b-a906-79167800cc17

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

August 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-