510(k) K090004
- Device
- LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
- Applicant
- LEVITRONIX LLC.
- 510(k) number
- K090004
- Product code
- DWA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-15
- Date received
- 2009-01-02
- Regulation
- 870.4380
- Classification name
- Control, Pump Speed, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- 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#
- 9617601
- 2029275
- 3012119238
- 2916596
- 3010163695
- 3019807891
- 1220648
- 9611109
- 3008792657
- 2184009
- 3014990448
- 3021562887
- 3015431638
- 1828100
- 2011171
- 3003306248
- 1218444
- 3010009632
- 3004593495
- 1928237
Source Documents#
Other 510(k) Records For Product Code DWA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232788 | INSPIRA ART100 | Inspira Technologies Oxy B.H.N. , Ltd. | 2024-05-24 |
| K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023-04-18 |
| K221491 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023-02-03 |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | Spectrum Medical , Ltd. | 2020-04-13 |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit | Abbott (Formerly Thoratec Corporation) | 2020-03-06 |
| K191557 | CentriMag Acute Circulatory Support System | Thoratec Corporation (Now Part of Abbott) | 2019-07-10 |
| K131964 | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE | Medtronic, Inc. | 2013-07-24 |
| K131179 | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR | Thoratec Corp | 2013-07-18 |
| K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) | Sorin Group Deutschland GmbH | 2011-09-20 |
| K103468 | STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS) | Sorin Group Deutschland GmbH | 2011-01-20 |
| K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | Levitronix, LLC | 2010-08-27 |
| K093832 | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | Levitronix, LLC | 2010-01-13 |
| K091008 | STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55 | Sorin Group Deutschland GmbH | 2009-07-15 |
| K083340 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | Levitronix, LLC | 2008-11-26 |
| K081221 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE | Levitronix, LLC | 2008-06-19 |
Legacy Summary#
summary
FDA Review#
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