# K070938: Thrombi-Paste Thrombin/Gelatin Powder Paste Hemostat

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Aug 6, 2007 after 124 days
- Product code: QSX (Hemostatic Wound Dressing With Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K896068 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012293: Vascular Solutions Duett Flowable Hemostat, Vascular Solutions, Inc. (2002) Summary page 5.
- K063860: Thrombigel Thrombin/Gelatin Foam Hemostat, Vascular Solutions, Inc. (2007) Summary page 5.

## Indications for use
The Thrombi-Paste® Thrombin/gelatin powder paste hemostat is applied topically for temporary control of moderate to severely bleeding wounds and for the local management of surface bleeding from vascular access sites and percutaneous tubes and catheters.

Source page: https://510kreport.com/device/K070938
Methodology: https://510kreport.com/methodology