LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
FDA 510(k) clearance K083340 · decided 2008-11-26
Clearance details
- K-number
- K083340
- Device name
- LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
- Applicant
- Levitronix, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-11-12
- Decision date
- 2008-11-26
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- DWA
- Device class
- 2
- Regulation number
- 870.4380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumpi recall (Z-0103-2019) | Thoratec Switzerland GMBH | 2018-10-12 |