510(k) K231414
K231414 is an FDA 510(k) premarket notification submitted by Chalice Medical , Ltd. for the device "CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)". The FDA issued a decision of Substantially Equivalent on November 1, 2023. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Chalice Medical , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2023
- Date Received
- May 16, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxygenator, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4350
- Review Panel
- CV
- Submission Type