# K070485: Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58L

- Pathway: 510(k) (Special)
- Applicant: Cardiva Medical, Inc.
- Decided: Mar 22, 2007 after 30 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: 2 generations back to K915280 (1992). 4 ancestors in all.
3 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)
- K051817: Boomerang Closurewire Vascular Closure System, Cardiva Medical, Inc. (2006)

## Most influential descendants
- K072297: Boomerang Catalyst/Boomerang Catalyst II System (2007), 2 descendants of its own
- 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 Wire/PlusWire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The BoomerangTM Wire/PlusWire 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/K070485
Methodology: https://510kreport.com/methodology