# K033709: Vascular Solutions D-Stat 2 Dry Hemostatic Bandage

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Dec 18, 2003 after 22 days
- Product code: QSX (Hemostatic Wound Dressing With Thrombin Or Other Biologics)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Vascular Solutions Inc., D-Stat Dry Hemostatic Bandage: named in the summary without a submission number

## Most influential descendants
- K040118: Vascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and the D-Stat 2 Dry Hemostatic (2004), 0 descendants of its own

## Recalls of this device
- Sep 9, 2005 · Not classified · Z-0144-06: A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which a

## Indications for use
The Vascular Solutions D-Stat 2 Dry Hemostatic Bandage 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/K033709
Methodology: https://510kreport.com/methodology