GALIX PACESTAR— 510(k) K023080

Substantially Equivalent

Galix Biomedical Instrumentation, Inc.

FDA 510(k) clearance K023080 for GALIX PACESTAR, Substantially Equivalent on 2003-06-11. Applicant: Galix Biomedical Instrumentation, Inc..

Clearance details

Applicant: Galix Biomedical Instrumentation, Inc.
Product code: Code DTE
Advisory panel: Cardiovascular
Date received: 2002-09-17
Decision date: 2003-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.