UMBILI-CATH CATHETER— 510(k) K802414

Substantially Equivalent

Int'L Corp.

FDA 510(k) clearance K802414 for UMBILI-CATH CATHETER, Substantially Equivalent on 1980-10-23. Applicant: Int'L Corp..

Clearance details

Applicant: Int'L Corp.
Product code: Code FOS
Advisory panel: General Hospital
Date received: 1980-10-03
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code FOS

product code FOS

Death: 12
Other: 1
Total: 13

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.