BLOOD FILTER, W/SET— 510(k) K771430

Substantially Equivalent

Terumo America, Inc.

FDA 510(k) clearance K771430 for BLOOD FILTER, W/SET, Substantially Equivalent on 1977-09-20. Applicant: Terumo America, Inc..

Clearance details

Applicant: Terumo America, Inc.
Product code: Code FPB
Advisory panel: General Hospital
Date received: 1977-08-01
Decision date: 1977-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.