# K040730: Vascular Solutions D-Stat Clamp Hemostatic Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jun 18, 2004 after 88 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: 4 generations back to K953781 (1995). 14 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002767: Compressar Femoral Access Compression Device, Semler Technologies, Inc. (2000) Summary page 2.
- K964662: Favc: Femoral Artery Vascular Clamp - Model Number RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15, Rmds, Inc. (1997) Summary page 2.
- K973216: Favc-HH: Femoral Artery Vascular Clamp-Hand Held: 1/2 & 3 Pounds (RMDS810T/815T/820T), Rmds, Inc. (1997) Summary page 2.
- K024107: Femostop Femoral Compression System, Radi Medical Systems AB (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage, Vascular Solutions, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K050146: Vascular Solutions D-Stat Clamp Accessory (2005), 16 descendants of its own
- 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

## 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 standalone device to assist in the control of bleeding following catheterization or cannulation procedures.

Source page: https://510kreport.com/device/K040730
Methodology: https://510kreport.com/methodology