PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR— 510(k) K870142

Substantially Equivalent

Cardio-Pace Medical, Inc.

FDA 510(k) clearance K870142 for PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR, Substantially Equivalent on 1987-04-22. Applicant: Cardio-Pace Medical, Inc..

Clearance details

Applicant: Cardio-Pace Medical, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1987-01-13
Decision date: 1987-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.