Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter— 510(k) K261403

Name: FDA 510(k) clearance K261403
Creator: U.S. Food and Drug Administration
Published: 2026-08-31

Substantially Equivalent

Global Life Sciences Solutions USA, LLC

FDA 510(k) clearance K261403 for Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter, Substantially Equivalent on 2026-08-31. Applicant: Global Life Sciences Solutions USA, LLC. Device class: 2.

Clearance details

Applicant: Global Life Sciences Solutions USA, LLC
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2026-04-29
Decision date: 2026-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.