Catalog Number

FG-000001

Brand Name

Cardica PAS-Port Proximal Anastomosis System

Version/Model Number

FG-000001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K091017

Product Code

FZP

Product Code Name

Clip, Implantable

Public Device Record Key

a2885cb9-3060-4173-b553-3df422c0bd46

Public Version Date

December 19, 2018

Public Version Number

5

DI Record Publish Date

August 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-