Search Results

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.

The D-Stat 2 Dry hemostatic bandage consists of the following components:

• Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and . calcium chloride
• Adhesive bandage .
  The D-Stat 2 Dry hemostatic bandage achieves their principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the adhesive bandage. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment, in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is an FDA 510(k) summary for a hemostatic bandage, stating that no clinical or additional non-clinical testing was conducted for this specific submission because its intended use is a "subset" of a previously cleared predicate device.

Therefore, I cannot provide the requested information.

Ask a specific question about this device