Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller
FDA 510(k) K936091 · Medtronic Bio-Medicus, Inc.
510(k) numberK936091
Submission
- Device name
- Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller
- Applicant
- Medtronic Bio-Medicus, Inc.
Eden Prairie, MN, US - Received
- December 22, 1993
- Decision date
- December 23, 1994
- 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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| K230698 | Anivia SG1000 Pump ConsoleDWA · Special | Apmtd, Inc. | 04/18/2023SE |
| K221491 | Anivia SG1000 Pump ConsoleDWA · Traditional | Apmtd, Inc. | 02/03/2023SE |
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| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…DWA · Special | Abbott (Formerly Thoratec Corporation) | 03/06/2020SE |
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| 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 |
More from Sorin Group Deutschland GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K973237 | Css-Cardioplegia Safety SystemDWB · Traditional | 04/27/1998SE |
| K973011 | BPX80 Bio-Pump (BPX80)KFM · Traditional | 02/25/1998SE |
| K954501 | Biotrend Oxygen Saturation & Hematocrit SystemDTY · Traditional | 01/16/1996SE |
| K941922 | Medsat Oxygen Saturation SystemDRY · Traditional | 02/17/1995SE |
| K941921 | Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550DWA · Traditional | 07/20/1994SE |
| K924208 | Bio-Probe(R) Blood Flow Monitoring SYST(TX-50/50P)DPT · Traditional | 07/08/1993SE |
| K926357 | Medtronic Bio-Medicus Handcrank Model 150DWA · Traditional | 06/02/1993SE |
| K924206 | Medtronic Bio-Medicus Bio-Console Model 540EDWA · Traditional | 05/07/1993SE |
| K924205 | Medtronic Bio-Medicus Bio-Console Model 550DWA · Traditional | 05/06/1993SE |
| K924642 | Medtronic Bio-Medicus Femoral Cannula/IntroducerDWF · Traditional | 03/26/1993SE |
Questions and answers
When was Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller cleared by the FDA?
Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller (K936091) received a 510(k) decision of Substantially Equivalent on December 23, 1994, 366 days after the submission was received.
What is the product code of K936091?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.