BIOVER— 510(k) K011208

Substantially Equivalent

Biover AG

FDA 510(k) clearance K011208 for BIOVER, Substantially Equivalent on 2002-10-02. Applicant: Biover AG.

Clearance details

Applicant: Biover AG
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2001-04-19
Decision date: 2002-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridley Park, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.