CATHETER, UMBILICAR ARTERY— 510(k) K771022

Substantially Equivalent

Axiom Medical, Inc.

FDA 510(k) clearance K771022 for CATHETER, UMBILICAR ARTERY, Substantially Equivalent on 1977-11-29. Applicant: Axiom Medical, Inc..

Clearance details

Applicant: Axiom Medical, Inc.
Product code: Code FOS
Advisory panel: General Hospital
Date received: 1977-06-06
Decision date: 1977-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.