K202154

Substantially Equivalent

B-Capta

Applicant
Livanova Deutschland, GmbH
Product code
DRY
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Munich, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code DRY

product code DRY
Death
5
Total
5

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.