Catalog Number

-

Brand Name

Cardiva VASCADE 5F VCS

Version/Model Number

700-500DX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

P120016,P120016,P120016

Product Code

MGB

Product Code Name

Device, Hemostasis, Vascular

Public Device Record Key

1a7a7400-f3e3-43b2-b217-ad7187ba4e33

Public Version Date

July 09, 2021

Public Version Number

8

DI Record Publish Date

December 29, 2015

Package DI Number

M729700500DX1

Quantity per Package

5

Contains DI Package

M729700500DX0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5-pk carton