SURGEN VALVE— 510(k) K990331

Substantially Equivalent

Tiva Medical

FDA 510(k) clearance K990331 for SURGEN VALVE, Substantially Equivalent on 2000-05-31. Applicant: Tiva Medical.

Clearance details

Applicant: Tiva Medical
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1999-02-02
Decision date: 2000-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.