INSPIRE 6M Hollow Fiber Oxygenator +3 more— 510(k) K180448
Substantially EquivalentSorin Group Italia S.R.L.
FDA 510(k) clearance K180448 for INSPIRE 6M Hollow Fiber Oxygenator +3 more, Substantially Equivalent on 2018-03-15. Applicant: Sorin Group Italia S.R.L.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Code DTZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mirandola, IT
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More clearances from Sorin Group Italia S.R.L.
view allAdverse 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.