CARDEON COBRA CATHETER— 510(k) K042156

Substantially Equivalent

Cardeon Corp.

FDA 510(k) clearance K042156 for CARDEON COBRA CATHETER, Substantially Equivalent on 2004-10-06. Applicant: Cardeon Corp..

Clearance details

Applicant: Cardeon Corp.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2004-08-10
Decision date: 2004-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.