3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System
FDA 510(k) K950739 · 3M Health Care, Sarns
510(k) numberK950739
Submission
- Device name
- 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System
- Applicant
- 3M Health Care, Sarns
Ann Arbor, MI, US - Received
- February 17, 1995
- Decision date
- November 17, 1995
- 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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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K960916 | Sams 8000 Cardioplegia MonitorDSJ · Traditional | 06/04/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 04/19/1996SE |
| K941653 | Sarns Turbo Membrane Oxygenator ModificationDTZ · Traditional | 08/24/1994SE |
| K941654 | Sarns Filtered Venous Reservior ModificationDTP · Traditional | 07/26/1994SE |
| K940651 | Sarns Ultrasonic Air SensorKRL · Traditional | 05/24/1994SE |
| K935391 | Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional | 02/24/1994SE |
| K934127 | Sarns Low Jetting Aortic Arch CannulaDWF · Traditional | 02/22/1994SE |
| K935977 | Sarns Air Detection SystemKRL · Traditional | 02/04/1994SE |
| K915547 | Sarns 8000 Delphin II Centri Pump Mod W/Integr BatKFM · Traditional | 09/09/1993SE |
| K925076 | Sarns Turbo Membrane Oxygena. W/Int. Cardiotomy R.DTZ · Traditional | 06/07/1993SE |
Questions and answers
When was 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System cleared by the FDA?
3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System (K950739) received a 510(k) decision of Substantially Equivalent on November 17, 1995, 273 days after the submission was received.
What is the product code of K950739?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.