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Cardiva VASCADE MVP VVCS 6-12F

FDA UDI

Class III (US FDA UDI)

by Cardiva Medical, Inc.

Identity

Trade Name
Cardiva VASCADE MVP VVCS 6-12F FDA UDI
Generic Name
Femoral artery closure plug/patch, collagen FDA UDI
Device Name
The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm. FDA UDI
Model / Reference
800-612C FDA UDI
Description
The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm. FDA UDI

Identifiers

Primary DI / UDI-DI
M729800612C0 FDA UDI
PMA Number
P120016 FDA UDI
FDA Product Code
MGB FDA UDI
GMDN Term
Femoral artery closure plug/patch, collagen FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Femoral artery closure plug/patch, collagen

Cardiva VASCADE MVP VVCS 6-12F by Cardiva Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral artery closure plug/patch, collagen.

Cleared under the same submission

P120016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardiva Medical, Inc.

Sources (1)

  • FDA UDI 96eabb31-a160-483e-87d4-4657e4757361 37 fields · synced Jun 9, 2026