DeviceClearance

K200083

Substantially Equivalent

EMBA Hourglass Peripheral Embolization Device (PED)

Applicant
Embolic Acceleration, LLC
Product code
KRD
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Miami, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KRD

product code KRD
Death
119
Injury
1,869
Malfunction
7,015
Other
1
Total
9,004

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.