DeviceClearance

K230008

Substantially Equivalent

Ablamap® System

Applicant
Ablacon, Inc.
Product code
DQK
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Denver, CO, 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.