GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER— 510(k) K052381

Substantially Equivalent

Zerusa Limited

FDA 510(k) clearance K052381 for GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER, Substantially Equivalent on 2005-11-21. Applicant: Zerusa Limited.

Clearance details

Applicant: Zerusa Limited
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2005-08-30
Decision date: 2005-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
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.