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FDA 510(k)

Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter

Número K: K261403 · 2026-08-31

RequerenteGlobal Life Sciences Solutions USA, LLC
Data da decisão2026-08-31
Código do produtoFPB
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter is the device name listed in this FDA 510(k) record. The listed applicant is Global Life Sciences Solutions USA, LLC. It received FDA 510(k) clearance on 2026-08-31 under 510(k) number K261403. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter?

Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter is a medical device that received FDA 510(k) clearance on 2026-08-31. The listed applicant is Global Life Sciences Solutions USA, LLC. The 510(k) number is K261403.

When did Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter receive FDA 510(k) clearance?

Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter received FDA 510(k) clearance on 2026-08-31, under 510(k) number K261403.

Who is the listed applicant for Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter?

The FDA 510(k) record lists Global Life Sciences Solutions USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter?

The FDA product code for Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter is FPB.

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Fonte oficial

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