# K072297: Boomerang Catalyst/Boomerang Catalyst II System

- Pathway: 510(k) (Special)
- Applicant: Cardiva Medical, Inc.
- Decided: Sep 12, 2007 after 26 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: 3 generations back to K915280 (1992). 5 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K070485: Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58L, Cardiva Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- K082930: Cardiva Catalyst Iii System with Protamine Sulfate (2009), 1 descendant of its own
- K130124: Catalyst II and Iii (2013), 0 descendants of its own

## Indications for use
The BoomerangTM Catalyst/Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The BoomerangTM Catalyst/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.

Source page: https://510kreport.com/device/K072297
Methodology: https://510kreport.com/methodology