5UM FILTERSET WITH Y-INJECTION SITE— 510(k) K771972

Name: FDA 510(k) clearance K771972
Creator: U.S. Food and Drug Administration
Published: 1978-01-03

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K771972 for 5UM FILTERSET WITH Y-INJECTION SITE, Substantially Equivalent on 1978-01-03. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1977-10-17
Decision date: 1978-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPB

view all

K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter2026-08-31
K233277 — Filter Needle for Single Use2024-05-10
K143583 — Cathivex ¿GV filter units2015-08-11
K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER2011-12-08
K021293 — ARTERIA BLOOD FILTER2002-08-22

More clearances from Abbott Laboratories

view all

K252424 — Anti-HCV Next2026-04-28
K243500 — ARCHITECT iGentamicin2025-07-09
K243168 — Alinity i Rubella IgG2025-06-20
K243283 — Alinity h-series System2025-02-20
K233932 — Alinity i Toxo IgM2024-08-30

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.