CATHETER METAL HUB/NONRADIOPAQUE— 510(k) K790968

Substantially Equivalent

Jelco Laboratories

FDA 510(k) clearance K790968 for CATHETER METAL HUB/NONRADIOPAQUE, Substantially Equivalent on 1979-06-11. Applicant: Jelco Laboratories.

Clearance details

Applicant: Jelco Laboratories
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1979-05-22
Decision date: 1979-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.