MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS— 510(k) K880326

Substantially Equivalent

Cardiac Control Systems, Inc.

FDA 510(k) clearance K880326 for MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS, Substantially Equivalent on 1988-04-11. Applicant: Cardiac Control Systems, Inc..

Clearance details

Applicant: Cardiac Control Systems, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1988-01-26
Decision date: 1988-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Coast, FL, US

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Adverse events under product code DXY

product code DXY

Death: 240
Injury: 2,328
Malfunction: 2,096
Total: 4,664

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.