# K061075: Boomerang Wire

- Pathway: 510(k) (Special)
- Applicant: Cardiva Medical, Inc.
- Decided: Sep 1, 2006 after 137 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.
13 later devices descend from it; 1 cites it directly.
0 of 17 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
- K091006: Itg Vascular Access System, Model 300 (2010), 12 descendants of its own
- K100615: Arstasis Access System (2010), 11 descendants of its own
- K102728: Arstasis Access System (2010), 10 descendants of its own
- K103143: Arstasis One Latchwire Access System (2011), 9 descendants of its own
- K113110: Axera Access System (2011), 8 descendants of its own

## Indications for use
The Cardiva Medical BoomerangTM Wire is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The BoomerangTM Wire is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.

Source page: https://510kreport.com/device/K061075
Methodology: https://510kreport.com/methodology