Vasopress Reprocessed Dvt Leg / Foot Garments
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112838 FDA 510(k)
- FDA Product Code
- JOW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5800 FDA 510(k)
- Regulation Number
- 870.5800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vasopress Reprocessed DVT Leg/Foot Garments are external pneumatic compression sleeves designed to prevent deep vein thrombosis (DVT). These garments apply graduated pressure to the legs or feet, promoting venous return and reducing the risk of clot formation in patients at risk for DVT.
The device is supplied as a single-use, reprocessed garment consisting of brushed nylon, foam, and tricot lining with an inflatable pressure bag made of PVC (for legs) or polyurethane (for feet). It connects to a pneumatic pump via an exit tube and is sterilized using ethylene oxide (EO) gas. The garments are classified under FDA regulation number 870.5800 and are authorized via FDA 510(k) clearance (K112838)
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: Vasopress™ - Zimmer Biomet | Vascular Compression Therapy, Vasopress Reprocessed Dvt Leg / Foot Garments, PDF The VasoPress® System Brochure - Zimmer Biomet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112838 | Class II | Active |
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Manufacturer
- Manufacturer
- Compression Therapy Concepts, Inc.
Sources (1)
- FDA 510(k) K112838 24 fields · synced Sep 19, 2026