MAPPING PROBE MODEL #6540— 510(k) K802058

Substantially Equivalent

Cardiac Pacemakers, Inc.

FDA 510(k) clearance K802058 for MAPPING PROBE MODEL #6540, Substantially Equivalent on 1980-11-19. Applicant: Cardiac Pacemakers, Inc..

Clearance details

Applicant: Cardiac Pacemakers, Inc.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1980-08-25
Decision date: 1980-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.