CARDIO-MEGA SYSTEM— 510(k) K871890

Substantially Equivalent

Grandcor Medical Systems

FDA 510(k) clearance K871890 for CARDIO-MEGA SYSTEM, Substantially Equivalent on 1987-06-12. Applicant: Grandcor Medical Systems.

Clearance details

Applicant: Grandcor Medical Systems
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1987-05-15
Decision date: 1987-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.