J&J SCALP VEIN INFUSION SETS— 510(k) K875177

Substantially Equivalent

Critikon Company, LLC

FDA 510(k) clearance K875177 for J&J SCALP VEIN INFUSION SETS, Substantially Equivalent on 1988-01-14. Applicant: Critikon Company, LLC.

Clearance details

Applicant: Critikon Company, LLC
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1987-12-22
Decision date: 1988-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, 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.