510(k) K191246
K191246 is an FDA 510(k) premarket notification submitted by Chalice Medical , Ltd. for the device "Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)". The FDA issued a decision of Substantially Equivalent on February 28, 2020. 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
- February 28, 2020
- Date Received
- May 9, 2019
- 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