LMI OCCLUSION CATHETER— 510(k) K955125

Substantially Equivalent

Lucas Medical, Inc.

FDA 510(k) clearance K955125 for LMI OCCLUSION CATHETER, Substantially Equivalent on 1996-03-11. Applicant: Lucas Medical, Inc..

Clearance details

Applicant: Lucas Medical, Inc.
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 1995-11-09
Decision date: 1996-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.