# K082930: Cardiva Catalyst Iii System with Protamine Sulfate

- Pathway: 510(k) (Traditional)
- Applicant: Cardiva Medical, Inc.
- Decided: Feb 13, 2009 after 135 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915280 (1992). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072297: Boomerang Catalyst/Boomerang Catalyst II System, Cardiva Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- K130124: Catalyst II and Iii (2013), 0 descendants of its own

## Indications for use
The Cardiva CatalystTM III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva CatalystTM III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

Source page: https://510kreport.com/device/K082930
Methodology: https://510kreport.com/methodology