BICORE SMARTVALVE OCCLUSION VALVE— 510(k) K921717

Substantially Equivalent

Bicore Monitoring Systems

FDA 510(k) clearance K921717 for BICORE SMARTVALVE OCCLUSION VALVE, Substantially Equivalent on 1992-11-06. Applicant: Bicore Monitoring Systems.

Clearance details

Applicant: Bicore Monitoring Systems
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 1992-04-09
Decision date: 1992-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.