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Cardiva VASCADE MVP XL VVCS 10-12F

FDA UDI

Class III (US FDA UDI)

by Cardiva Medical, Inc.

Identity

Trade Name
Cardiva VASCADE MVP XL VVCS 10-12F FDA UDI
Generic Name
Femoral artery closure plug/patch, collagen FDA UDI
Device Name
The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F 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 10Fr 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
800-1012XL FDA UDI
Description
The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F 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 10Fr 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
M7298001012XL0 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 XL VVCS 10-12F 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 1fc1d316-5093-4b87-ae5c-76929286ea11 37 fields · synced Jun 9, 2026