Davol Cardiovascular Autotransfusion Unit
FDA 510(k)Class II (US FDA 510(k))
by Davol Inc.
Identifiers
- 510(k) Number
- K931552 FDA 510(k)
- FDA Product Code
- CAC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5830 FDA 510(k)
- Regulation Number
- 868.5830 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Davol Cardiovascular Autotransfusion Unit is an autotransfusion apparatus, a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma. It is classified as an Apparatus, Autotransfusion, with a product code of CAC and regulation number 868.5830.
The device is supplied by Davol Inc. and has been cleared with FDA 510(k) number K931552. It is intended for use in anesthesiology and has been assigned a device class of 2. The device is used to collect and reinfuse blood, and its specifications and clearances are on record with the FDA.
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: DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT (K931552) — FDA 510(k ..., 510(k) K931552 — DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT, Davol, Inc. FDA 510 (k) Products - Latest 2025
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K931552 | Class II | Active |
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Manufacturer
- Manufacturer
- Davol Inc.
- FDA Applicant
- Davol, Inc.
Sources (1)
- FDA 510(k) K931552 24 fields · synced Sep 24, 2026