Cardiva Catalyst III VCS

FDA UDI

Class II (US FDA UDI)

by Cardiva Medical, Inc.

Identity

Trade Name: Cardiva Catalyst III VCS FDA UDI
Generic Name: Femoral artery medicated closure set FDA UDI
Device Name: The Cardiva Catalyst III consists of a sterile disposable Catalyst III Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III is specifically designed for use with heparinized patients. The Cardiva Catalyst III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst III is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths. FDA UDI
Model / Reference: 600-580CP FDA UDI
Description: The Cardiva Catalyst III consists of a sterile disposable Catalyst III Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III is specifically designed for use with heparinized patients. The Cardiva Catalyst III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst III is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths. FDA UDI

Identifiers

Primary DI / UDI-DI: M729600580CP0 FDA UDI
FDA Product Code: DXC FDA UDI
GMDN Term: Femoral artery medicated closure set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4450 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 6 French FDA UDI
Catheter Gauge — 7 French FDA UDI
Catheter Gauge — 5 French FDA UDI

Cardiva Catalyst III VCS by Cardiva Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Cardiva Medical, Inc.

Sources (1)

FDA UDI b3016f7d-9460-4375-a865-92d47d4c389e 37 fields · synced Jun 9, 2026