510(k) K200683— INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir

Substantially Equivalent

Sorin Group Italia S.R.L.

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2020-03-16
Decision date: 2020-06-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Mirandola, IT

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.