PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)— 510(k) K954331

Name: FDA 510(k) clearance K954331
Creator: U.S. Food and Drug Administration
Published: 1997-01-09

Substantially Equivalent

Pall Biomedical Products Co.

FDA 510(k) clearance K954331 for PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER), Substantially Equivalent on 1997-01-09. Applicant: Pall Biomedical Products Co.. Device class: 2.

Clearance details

Applicant: Pall Biomedical Products Co.
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1995-09-15
Decision date: 1997-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Hills, NY, US

Download summary PDF View on FDA.gov ↗

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K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)1996-04-22
K905794 — PALL 3N1 FILTER1991-06-13
K902518 — LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE1990-10-16
K884534 — PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER1989-01-24
K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE1988-02-29

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.