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Dale Venipuncture Tourniquet, Product No. 1335
FDA 510(k)Class I (US FDA 510(k))
510(k) K864897
Identifiers
- 510(k) Number
- K864897 FDA 510(k)
- FDA Product Code
- GAX FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5900 FDA 510(k)
- Regulation Number
- 878.5900 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Dale Venipuncture Tourniquet, Product No. 1335 by Dale Medical Products, Inc. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K864897 | Class I | Active |
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Manufacturer
- Manufacturer
- Dale Medical Products, Inc.
Sources (1)
- FDA 510(k) K864897 24 fields · synced Jun 18, 2026