GUARDIAN II HEMOSTASIS VALVE— 510(k) K092711

Substantially Equivalent

Zerusa Limited

FDA 510(k) clearance K092711 for GUARDIAN II HEMOSTASIS VALVE, Substantially Equivalent on 2009-10-01. Applicant: Zerusa Limited.

Clearance details

Applicant: Zerusa Limited
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2009-09-03
Decision date: 2009-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.