# K063871: D-Stat Handle, Model 8500-053

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Feb 28, 2007 after 61 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: 6 generations back to K953781 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050146: Vascular Solutions D-Stat Clamp Accessory, Vascular Solutions, Inc. (2005) Summary page 1.
- K915280: Femostop, Radi Medical Systems AB (1992) Summary page 1.
- K973132: EZ Hold 1 LBS., EZ Hold 2 LBS, Tz Medical, Inc. (1998) Summary page 1.

## Indications for use
The D-Stat Handle is indicated for use with the D-Stat Clamp accessory to assist in the control of bleeding following catheterization or cannulation procedures. 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/K063871
Methodology: https://510kreport.com/methodology