# K041486: Vasostasis Vascular Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiva Medical, Inc.
- Decided: Oct 22, 2004 after 140 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
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FemoStop™ System: named in the summary without a submission number
- (no number) COMPRESSAR® Universal System: named in the summary without a submission number
- (no number) CTS FloCoil™ Shunt: named in the summary without a submission number
- (no number) Flo-Rester® Internal Vessel Occluder: named in the summary without a submission number

## Most influential descendants
- K061075: Boomerang Wire (2006), 13 descendants of its own
- 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

## Indications for use
The Cardiva Medical VasoStasis TM Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis Vascular Closure System 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/K041486
Methodology: https://510kreport.com/methodology