IV FILTERSET 5 MICROMETER— 510(k) K813445

Name: FDA 510(k) clearance K813445
Creator: U.S. Food and Drug Administration
Published: 1982-01-05

Substantially Equivalent

Imed Corp.

FDA 510(k) clearance K813445 for IV FILTERSET 5 MICROMETER, Substantially Equivalent on 1982-01-05. Applicant: Imed Corp.. Device class: 2.

Clearance details

Applicant: Imed Corp.
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1981-12-09
Decision date: 1982-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.