510(k) K192838
K192838 is an FDA 510(k) premarket notification submitted by Spectrum Medical , Ltd. for the device "Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure". The FDA issued a decision of Substantially Equivalent on April 13, 2020. The device falls under product code DWA (Control, Pump Speed, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4380. Spectrum Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2020
- Date Received
- October 3, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Pump Speed, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4380
- Review Panel
- CV
- Submission Type