Sarns 8000 Delphin II Centri Pump Mod W/Integr Bat
FDA 510(k) K915547 · 3M Health Care, Sarns
510(k) numberK915547
Submission
- Device name
- Sarns 8000 Delphin II Centri Pump Mod W/Integr Bat
- Applicant
- 3M Health Care, Sarns
Ann Arbor, MI, US - Received
- December 11, 1991
- Decision date
- September 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KFM – Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4360
- Specialty
- Cardiovascular
Other 510(k)s with product code KFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)KFM · Traditional | Spectrum Medical S.R.L. | 08/04/2025SE |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)KFM · Traditional | Spectrum Medical S.R.L. | 06/24/2025SE |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)…KFM · Special | Qura S.R.L | 10/26/2023SE |
| K232132 | LifeSPARC SystemKFM · Special | Cardiacassist, Inc. | 08/03/2023SE |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion…KFM · Traditional | Qura S.R.L | 05/19/2023SE |
| K200091 | Capiox iCP Centrifugal PumpKFM · Traditional | Terumo Cardiovascular Systems Corporation | 11/18/2021SE |
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorKFM · Traditional | Qura S.R.L | 11/03/2021SE |
| K193663 | FloPump 57mL Centrifugal PumpKFM · Traditional | International Biophysics Corporation | 03/10/2021SE |
| K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22KFM · Special | Qura S.R.L | 09/02/2020SE |
| K201068 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance…KFM · Special | Medtronic, Inc. | 05/21/2020SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960916 | Sams 8000 Cardioplegia MonitorDSJ · Traditional | 06/04/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 04/19/1996SE |
| K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion SystemDWA · Traditional | 11/17/1995SE |
| 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 |
| K925076 | Sarns Turbo Membrane Oxygena. W/Int. Cardiotomy R.DTZ · Traditional | 06/07/1993SE |
Questions and answers
When was Sarns 8000 Delphin II Centri Pump Mod W/Integr Bat cleared by the FDA?
Sarns 8000 Delphin II Centri Pump Mod W/Integr Bat (K915547) received a 510(k) decision of Substantially Equivalent on September 9, 1993, 638 days after the submission was received.
What is the product code of K915547?
The FDA product code is KFM – Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4360.