Clearance Summary
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 received FDA 510(k) clearance under submission number K180448, sponsored by Sorin Group Italia S.R.L.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2018-03-15.
- Submission: K180448
- Applicant / Sponsor: Sorin Group Italia S.R.L.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4350
- Decision date: 2018-03-15
Classification & Regulation
This clearance is catalogued under FDA product code DTZ and 21 CFR 870.4350, within the Cardiovascular review panel as a Class II device.