F.A.S.T. SYSTEM SED AND CXD— 510(k) K092623

Substantially Equivalent

Genesis Medical Interventional, Inc.

FDA 510(k) clearance K092623 for F.A.S.T. SYSTEM SED AND CXD, Substantially Equivalent on 2009-10-30. Applicant: Genesis Medical Interventional, Inc..

Clearance details

Applicant: Genesis Medical Interventional, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2009-08-26
Decision date: 2009-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

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Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.