DeviceClearance

K180448

Substantially Equivalent

INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter

Applicant
Sorin Group Italia S.R.L.
Product code
DTZ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mirandola, IT
Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ
Death
182
Injury
422
Malfunction
3,636
Total
4,240

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.