DeviceClearance

K002976

Substantially Equivalent

RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX

Applicant
St Jude Medical
Product code
DRF
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minnetonka, MN, 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.