Clearance Summary
MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR received FDA 510(k) clearance under submission number K004001, sponsored by Dideco. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-10-04.
- Submission: K004001
- Applicant / Sponsor: Dideco
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4350
- Decision date: 2001-10-04
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.