# K130124: Catalyst II and Iii

- Pathway: 510(k) (Traditional)
- Applicant: Cardiva Medical, Inc.
- Decided: Mar 14, 2013 after 56 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: 5 generations back to K915280 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082930: Cardiva Catalyst Iii System with Protamine Sulfate, Cardiva Medical, Inc. (2009) Summary page 1.
- K072297: Boomerang Catalyst/Boomerang Catalyst II System, Cardiva Medical, Inc. (2007) Summary page 1.
- K070485: Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58L, Cardiva Medical, Inc. (2007) Summary page 1.

## Indications for use
The Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths. The Catalyst III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Catalyst 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/K130124
Methodology: https://510kreport.com/methodology