CARDEON ASCENDING BALLOON CANNULA (ABC)— 510(k) K001371

Substantially Equivalent

Cardeon Corp.

FDA 510(k) clearance K001371 for CARDEON ASCENDING BALLOON CANNULA (ABC), Substantially Equivalent on 2000-07-07. Applicant: Cardeon Corp..

Clearance details

Applicant: Cardeon Corp.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2000-05-01
Decision date: 2000-07-07
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.