LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
FDA 510(k) clearance K020271 · decided 2003-03-25
Clearance details
- K-number
- K020271
- Device name
- LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
- Applicant
- Levitronix, LLC
- Decision
- Substantially Equivalent
- Date received
- 2002-01-28
- Decision date
- 2003-03-25
- Days to decision
- 421 days
- Clearance type
- Abbreviated
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- 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 |
|---|---|---|
| CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-1000 recall (Z-0221-2020) | Thoratec Switzerland GMBH | 2019-10-30 |
| Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumpi recall (Z-0103-2019) | Thoratec Switzerland GMBH | 2018-10-12 |
| Levitronix CentriMag Primary System, Article Number: 201-30100; extracorporeal blood circu recall (Z-1901-2008) | Levitronix, Llc | 2008-07-23 |