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K Number
K033709
Device Name
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
Manufacturer
VASCULAR SOLUTIONS, INC.
Date Cleared
2003-12-18

(22 days)

Product Code
QSX,FRO
Regulation Number
N/A
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

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.
AI/ML Overview

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.

N/A