PBC SCALP VEIN SET— 510(k) K834255

Substantially Equivalent

Philadelphia Biologics Center

FDA 510(k) clearance K834255 for PBC SCALP VEIN SET, Substantially Equivalent on 1984-03-12. Applicant: Philadelphia Biologics Center.

Clearance details

Applicant: Philadelphia Biologics Center
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1983-12-07
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.