# K012293: Vascular Solutions Duett Flowable Hemostat

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jan 18, 2002 after 182 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: 2 generations back to K896068 (1990). 3 ancestors in all.
45 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984177: Modification to Skvekpatch, Marine Polymer Technologies, Inc. (1998) Summary page 6.
- K982818: Hospal Tipstop, Gambro Healthcare (1998) Summary page 6.

## Most influential descendants
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage (2003), 44 descendants of its own
- K050511: Thrombigel Thrombin/Gelatin Foam Hemostat (2005), 25 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K050146: Vascular Solutions D-Stat Clamp Accessory (2005), 16 descendants of its own
- K053300: Syvekexcel (2006), 14 descendants of its own

## Indications for use
The Vascular Solutions Duett Flowable Hemostat is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes.

Source page: https://510kreport.com/device/K012293
Methodology: https://510kreport.com/methodology