DeviceClearance

K965066

Substantially Equivalent

ARRHYTHMIA MAPPING SYSTEM (8100/8300)

Applicant
Cardiac Pathways Corp.
Product code
DRF
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunnyvale, CA, 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, through . 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.