# K050146: Vascular Solutions D-Stat Clamp Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: May 27, 2005 after 123 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
Longest line of descent: 5 generations back to K953781 (1995). 20 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040730: Vascular Solutions D-Stat Clamp Hemostatic Clamp, Vascular Solutions, Inc. (2004) Summary page 1.
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage, Vascular Solutions, Inc. (2003) Summary page 1.

## Most influential descendants
- K053300: Syvekexcel (2006), 14 descendants of its own
- K061219: D-Stat Dry Hemostatic Bandage (2006), 13 descendants of its own
- K090620: Quikclot Inteventional, Model P/N 182 (2009), 5 descendants of its own
- K072890: Stasilon FR (2007), 5 descendants of its own
- K142363: Nustat, Nustat XR (2015), 4 descendants of its own

## Indications for use
The D-Stat Clamp Accessory is indicated for use with the Compressar Universal System (Advanced Vascular Dynamics) and the Femoral Artery Vascular Clamp (Pressure Products) compression devices or as a stand alone device to assist in the control of bleeding following catheterization or cannulation procedures. Following achieving hemostasis the D-Stat Dry Bandage may be detached from the D-Stat Clamp Accessory and left in place for up to 24 hours and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

Source page: https://510kreport.com/device/K050146
Methodology: https://510kreport.com/methodology