Clearance Summary
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W received FDA 510(k) clearance under submission number K061031, 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 2006-06-02.
- Submission: K061031
- 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: 2006-06-02
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.