Identifiers
- 510(k) Number
- K040456 FDA 510(k)
- FDA Product Code
- LHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5440 FDA 510(k)
- Regulation Number
- 880.5440 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FleboSet Multiple is a disposable transfer set (product code LHI) designed for the continuous transfer of substances between two vials containing the same solution. It falls under the nomenclature for infusion sets and transfer sets, facilitating controlled fluid administration when paired with gravity or pump infusion systems.
This device is supplied as a single-use, sterile transfer set, intended for intravenous (IV) administration in general hospital settings. It connects via luer-lock to a drip chamber, enabling seamless transfer from source vials to the infusion pathway. Authorized under FDA 510(k) clearance (K040456), it adheres to traditional review standards and is distributed by Laboratorios Grifols, S.A.
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: FLEBOSET MULTIPLE (K040456) — FDA 510 (k) | Innolitics, LABORATORIOS GRIFOLS SA - RevMed, PDF GRIFOLS TECHNICAL EVALUATION I# o ziC DOCUMENTATION I TED-PLEBOSET ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040456 | Class II | Active |
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Manufacturer
- Manufacturer
- Laboratorios Grifols, S.a.
Sources (1)
- FDA 510(k) K040456 24 fields · synced Sep 19, 2026