CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR— 510(k) K853425

Substantially Equivalent

Cardio-Pace Medical, Inc.

FDA 510(k) clearance K853425 for CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR, Substantially Equivalent on 1985-08-19. Applicant: Cardio-Pace Medical, Inc..

Clearance details

Applicant: Cardio-Pace Medical, Inc.
Product code: Code DXY
Advisory panel: Cardiovascular
Date received: 1985-08-14
Decision date: 1985-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, 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.