AB CARDIETTE START 200 HV— 510(k) K010822

Substantially Equivalent

H&C Medical Devices Spa

FDA 510(k) clearance K010822 for AB CARDIETTE START 200 HV, Substantially Equivalent on 2001-04-18. Applicant: H&C Medical Devices Spa.

Clearance details

Applicant: H&C Medical Devices Spa
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2001-03-19
Decision date: 2001-04-18
Decision: Substantially Equivalent
Clearance type: Special
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.