# K051817: Boomerang Closurewire Vascular Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiva Medical, Inc.
- Decided: Dec 6, 2006 after 519 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: 1 generation back to K915280 (1992). 3 ancestors in all.
4 later devices descend 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)
- K041486: Vasostasis Vascular Closure System, Cardiva Medical, Inc. (2004) Summary page 1.
- K915280: Femostop, Radi Medical Systems AB (1992) Summary page 1.
- K970638: CTS Midcab Fixedn Diameter Coronary Shunt, Cardiothoracic Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K070485: Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58L (2007), 3 descendants of its own
- 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 Boomerang TM Wire System is intended to promote hemostasis at an arteriotomy site as an adjunct to manual compression. The Boomerang TM Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5, 6 or 7 Fr introducer sheaths.

Source page: https://510kreport.com/device/K051817
Methodology: https://510kreport.com/methodology