Vascular Solutions D-Stat Clamp Hemostatic Clamp
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040730 FDA 510(k)
- FDA Product Code
- DXC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vascular Solutions D-Stat Clamp Hemostatic Clamp is a vascular clamp designed to achieve hemostasis through physical compression and the enzymatic conversion of fibrinogen to fibrin. It consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride, which is secured to a compressible foam pad and a plastic base.
This device is intended to assist in the control of bleeding following catheterization or cannulation procedures, either as a stand-alone device or for use with compatible compression systems. It is authorized via FDA 510k clearance under K040730. The thrombin contained within the product must not be injected intra-vascularly.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vascular Solutions D-stat Clamp Hemostatic Clamp, PDF Vascular Solutions D-Stat® Flowable Hemostat, PDF vsascular - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040730 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA 510(k) K040730 24 fields · synced Sep 26, 2026