DeviceClearance

K163693

Substantially Equivalent

IntraClude Intra-Aortic Occlusion Device

Applicant
Edwards Lifesciences, LLC
Product code
DXC
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Irvine, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC
Death
14
Injury
442
Malfunction
2,209
Other
1
Total
2,666

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.