EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE— 510(k) K042060

Substantially Equivalent

Millimed A/S

FDA 510(k) clearance K042060 for EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE, Substantially Equivalent on 2004-10-06. Applicant: Millimed A/S.

Clearance details

Applicant: Millimed A/S
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2004-07-30
Decision date: 2004-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gambrills, MD, 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.