H-FLOW VALVE— 510(k) K034043

Substantially Equivalent

Elcam Medical Acal

FDA 510(k) clearance K034043 for H-FLOW VALVE, Substantially Equivalent on 2004-06-30. Applicant: Elcam Medical Acal.

Clearance details

Applicant: Elcam Medical Acal
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2003-12-29
Decision date: 2004-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mp. Merom Hagalil, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.