Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
FDA 510(k) K192838 · Spectrum Medical , Ltd.
510(k) numberK192838
Submission
- Device name
- Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
- Applicant
- Spectrum Medical , Ltd.
Gloucester, GB - Received
- October 3, 2019
- Decision date
- April 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWA – Control, Pump Speed, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4380
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K191557 | CentriMag Acute Circulatory Support SystemDWA · Special | Thoratec Corporation (Now Part of Abbott) | 07/10/2019SE |
| K131964 | Bio-Console 560 Extracorporeal Blood Pumping ConsoleDWA · Special | Medtronic, Inc. | 07/24/2013SE |
| K131179 | Centrimag Primary Console (2ND Generation); Mag MonitorDWA · Special | Thoratec Corp | 07/18/2013SE |
| K112225 | Sorin Centrifugal Pump 5 (CP5)DWA · Special | Sorin Group Deutschland GmbH | 09/20/2011SE |
| K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)DWA · Traditional | Sorin Group Deutschland GmbH | 01/20/2011SE |
| K102129 | Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorDWA · Special | Levitronix, LLC | 08/27/2010SE |
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Questions and answers
When was Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure cleared by the FDA?
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure (K192838) received a 510(k) decision of Substantially Equivalent on April 13, 2020, 193 days after the submission was received.
What is the product code of K192838?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.