DeviceClearance

K243892

Substantially Equivalent

Affera Integrated Mapping System

Applicant
Medtronic, Inc.
Product code
DQK
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mounds View, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK
Death
10
Injury
225
Malfunction
2,123
Other
2
Total
2,360

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.