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Cardiva VASCADE 6/7F VCS

FDA UDI

Class III (US FDA UDI)

by Cardiva Medical, Inc.

Identity

Trade Name
Cardiva VASCADE 6/7F VCS FDA UDI
Generic Name
Femoral artery closure plug/patch, collagen FDA UDI
Device Name
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm. FDA UDI
Model / Reference
700-580I FDA UDI
Description
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm. FDA UDI

Identifiers

Primary DI / UDI-DI
M729700580I0 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

Dimensions & Sizes

Size
Catheter Gauge — 7 French FDA UDI
Catheter Gauge — 6 French FDA UDI

Category: Femoral artery closure plug/patch, collagen

Cardiva VASCADE 6/7F VCS 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 a2fb250d-3cd4-4851-8248-0f9a5d5f26f0 37 fields · synced Jun 9, 2026