K101113

Substantially Equivalent

GUARDIAN II NC HEMOSTASIS VALVE

Applicant: Zerusa Limited
Product code: DTL
Advisory panel: Cardiovascular
Date received: 2010-04-21
Decision date: 2010-05-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

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.