510(k) K090051
- Device
- LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
- Applicant
- LEVITRONIX LLC.
- 510(k) number
- K090051
- Product code
- KFM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-10-08
- Date received
- 2009-01-07
- Regulation
- 870.4360
- Classification name
- Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN HAMANN
- Address
- 45 First Ave. Waltham MA US 02451 02451
FDA Registration Numbers#
- 3006073153
- 9617601
- 2029275
- 2528981
- 3012119238
- 2916596
- 9681834
- 3010163695
- 1422634
- 3016746283
- 1123137
- 3019807891
- 1220648
- 3009507273
- 3011554160
- 3008792657
- 2184009
- 3014990448
- 3006849754
- 3009380063
- 3005941719
- 1828100
- 3003661577
- 2011171
- 1124841
- 3003306248
- 1218444
- 1319639
- 3030125051
- 9680841
- 8010026
- 1928237
- 3002807090
- 8010762
- 3007427881
Source Documents#
Other 510(k) Records For Product Code KFM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) | Spectrum Medical S.R.L. | 2025-08-04 |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) | Spectrum Medical S.R.L. | 2025-06-24 |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) | Qura S.R.L | 2023-10-26 |
| K232132 | LifeSPARC System | Cardiacassist, Inc. | 2023-08-03 |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors | Qura S.R.L | 2023-05-19 |
| K200091 | Capiox iCP Centrifugal Pump | Terumo Cardiovascular Systems Corporation | 2021-11-18 |
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | Qura S.R.L | 2021-11-03 |
| K193663 | FloPump 57mL Centrifugal Pump | International Biophysics Corporation | 2021-03-10 |
| K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | Qura S.R.L | 2020-09-02 |
| K201068 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface | Medtronic, Inc. | 2020-05-21 |
| K192850 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 | Qura S.R.L | 2020-04-13 |
| K191077 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor | Medtronic, Inc. | 2019-08-27 |
| K190650 | Revolution Centrifugal Blood Pump | Sorin Group Italia S.R.L. | 2019-08-07 |
| K183623 | LifeSPARC Pump, LifeSPARC Controller | Cardiacassist, Inc. | 2019-07-09 |
| K170029 | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | International Biophysics Corporation | 2017-12-15 |
Legacy Summary#
summary
FDA Review#
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