Cardiva Catalyst III VCS

Basic Information

• Brand Name: Cardiva Catalyst III VCS
• Primary DI: M729600580CP0
• Version / Model: 600-580CP
• Company Name: CARDIVA MEDICAL, INC.
• Labeler DUNS: 128112195
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-29
• Public Version: 4
• Public Version Date: 2025-03-04
• Public Version Status: Update
• Public Device Record Key: b3016f7d-9460-4375-a865-92d47d4c389e
• Distribution End Date: 2024-09-20

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63107	Femoral artery medicated closure set	A collection of hand-operated instruments, which includes a pharmaceutical agent, intended for the percutaneous closure of a femoral artery or vein puncture site, following a catheterization procedure, in patients using an anticoagulant medication (e.g., heparin). The collection typically consists of a catheter/sheath which elutes the pharmaceutical agent, intended to locally reverse the effect of the anticoagulant, and a haemostatic plug intended to be temporarily placed within the artery; implantable devices are not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M729600580CP2	HIBCC	10-pk carton	10	Not in Commercial Distribution	2024-09-20
Primary	M729600580CP0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French
Catheter Gauge	7	French
Catheter Gauge	5	French

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 25 Degrees Celsius