GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE— 510(k) K122301

Substantially Equivalent

Vascular Solutions Zerusa , Ltd.

FDA 510(k) clearance K122301 for GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE, Substantially Equivalent on 2012-09-07. Applicant: Vascular Solutions Zerusa , Ltd..

Clearance details

Applicant: Vascular Solutions Zerusa , Ltd.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2012-08-01
Decision date: 2012-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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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.