PROTHROMBIN FREE BEEF PLASMA (PFB)— 510(k) K791023

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K791023 for PROTHROMBIN FREE BEEF PLASMA (PFB), Substantially Equivalent on 1979-06-28. Applicant: Pacific Hemostasis.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GJS
Advisory panel: Hematology
Date received: 1979-05-30
Decision date: 1979-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.