Ibc Flopump, Model 6000
FDA 510(k) K983272 · International Biophysics Corp.
510(k) numberK983272
Submission
- Device name
- Ibc Flopump, Model 6000
- Applicant
- International Biophysics Corp.
Austin, TX, US - Received
- September 17, 1998
- Decision date
- March 24, 1999
- 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 |
|---|---|---|
| K193663 | FloPump 57mL Centrifugal PumpKFM · Traditional | 03/10/2021SE |
| K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-SterileKFM · Traditional | 12/15/2017SE |
| K122480 | International Biophysics Corporation AfflovestBYI · Traditional | 03/27/2013SE |
| K072688 | Lifechoice Oxygen Concentrator, Model OXY1000CAW · Abbreviated | 01/11/2008SE |
| K030181 | International Biophysics Corporation (Ibc) Laser Peel SystemGEX · Traditional | 04/17/2003SE |
| K992657 | Ibc VRV, Model 1350DWD · Traditional | 02/18/2000SE |
| K992785 | Ibc Floguard, Model 6050MJJ · Traditional | 01/14/2000SE |
| K992964 | Ibc Vent Valve, Model 1400MNJ · Traditional | 11/19/1999SE |
| K963703 | Accuflo Monitoring System (1800)/ Accuflo Probe (8000)DPT · Traditional | 04/08/1998SE |
| K963756 | Ibc Cardiac Suction WardDTS · Traditional | 11/14/1997SE |
Questions and answers
When was Ibc Flopump, Model 6000 cleared by the FDA?
Ibc Flopump, Model 6000 (K983272) received a 510(k) decision of Substantially Equivalent on March 24, 1999, 188 days after the submission was received.
What is the product code of K983272?
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.