ECLIPSE HEART SUPPORT FOR CORONARY ARTER— 510(k) K843216

Substantially Equivalent

Biotrac Laboratories

FDA 510(k) clearance K843216 for ECLIPSE HEART SUPPORT FOR CORONARY ARTER, Substantially Equivalent on 1984-09-20. Applicant: Biotrac Laboratories.

Clearance details

Applicant: Biotrac Laboratories
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 1984-08-15
Decision date: 1984-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.