Cardiva VASCADE MVP VVCS 6-12F - The VASCADE MVP Venous Vascular Closure System - CARDIVA MEDICAL, INC.

Duns Number:128112195

Device Description: The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins wi

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More Product Details

Catalog Number

-

Brand Name

Cardiva VASCADE MVP VVCS 6-12F

Version/Model Number

800-612C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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,P120016

Product Code Details

Product Code

MGB

Product Code Name

Device, Hemostasis, Vascular

Device Record Status

Public Device Record Key

96eabb31-a160-483e-87d4-4657e4757361

Public Version Date

July 12, 2021

Public Version Number

5

DI Record Publish Date

November 28, 2018

Additional Identifiers

Package DI Number

M729800612C2

Quantity per Package

10

Contains DI Package

M729800612C0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CARDIVA MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2