# K040118: Vascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and the D-Stat 2 Dry Hemostatic

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Feb 12, 2004 after 23 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: 4 generations back to K896068 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage, Vascular Solutions, Inc. (2003) Summary page 4.
- K033709: Vascular Solutions D-Stat 2 Dry Hemostatic Bandage, Vascular Solutions, Inc. (2003) Summary page 4.
- (no number) D-Stat Dry Hemostatic Bandage: named in the summary without a submission number

## Indications for use
....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/K040118
Methodology: https://510kreport.com/methodology