AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES— 510(k) K002074

Substantially Equivalent

H&C Medical Devices Spa

FDA 510(k) clearance K002074 for AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES, Substantially Equivalent on 2000-10-04. Applicant: H&C Medical Devices Spa.

Clearance details

Applicant: H&C Medical Devices Spa
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2000-07-10
Decision date: 2000-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.