Clearance Summary
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) received FDA 510(k) clearance under submission number K231414, sponsored by Chalice Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-11-01.
- Submission: K231414
- Applicant / Sponsor: Chalice Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4350
- Decision date: 2023-11-01
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.