FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
K Number: K081221
·
Decision Jun 19, 2008
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
36
Applicant Total
11
Review Days
50
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Basic Information
- Device Name
- LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
- K Number
- K081221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Levitronix, LLC
- Date Received
- April 30, 2008
- Decision Date
- June 19, 2008
- Product Code
- DWA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Levitronix, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K110983 | CENTRIMAG DRAINAGE CANNULA KIT | Jun 20, 2011 | Substantially Equivalent |
| K110980 | CENTRIMAG RETURN CANNULA KIT | Jun 20, 2011 | Substantially Equivalent |
| K102129 | LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR | Aug 27, 2010 | Substantially Equivalent |
| K093832 | LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES | Jan 13, 2010 | Substantially Equivalent |
| K090051 | LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 | Oct 8, 2009 | Substantially Equivalent |
| K090004 | LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES | Jan 15, 2009 | Substantially Equivalent |
| K083340 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE | Nov 26, 2008 | Substantially Equivalent |
| K053630 | LEVITRONIX CENTRIMAG PRIMARY CONSOLE | Jan 26, 2006 | Substantially Equivalent |
| K051209 | LEVITRONIX CENTRIMAG BACK-UP CONSOLE | Sep 8, 2005 | Substantially Equivalent |
| K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 | Mar 25, 2003 | Substantially Equivalent |