# K071225: Innovasa Stat*Seal Topical Hemostat

- Pathway: 510(k) (Traditional)
- Applicant: Innovasa, Inc.
- Decided: Aug 31, 2007 after 121 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Stat-Seal is indicated for use following femoral vascular catheterization procedures to assist in obtaining hemostasis.

Source page: https://510kreport.com/device/K071225
Methodology: https://510kreport.com/methodology