510(k) clearance
Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
- 510(k) number
- K261403
- Applicant
- Global Life Sciences Solutions USA, LLC
- Decision date
- Aug 31, 2026
- Date received
- Apr 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FPB
- Device type
- Filter, Infusion Line
- Device class
- Class II
- Regulation
- 21 CFR 880.5440
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Marlborough, MA, US