CATHETER THORACIC, AXIOM— 510(k) K770983

Substantially Equivalent

Axiom Medical, Inc.

FDA 510(k) clearance K770983 for CATHETER THORACIC, AXIOM, Substantially Equivalent on 1977-07-29. Applicant: Axiom Medical, Inc..

Clearance details

Applicant: Axiom Medical, Inc.
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1977-05-31
Decision date: 1977-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.