Atlas FDA

CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR

FDA 510(k) clearance K131179 · decided 2013-07-18

Clearance details

K-number
K131179
Device name
CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR
Applicant
Thoratec Corp
Decision
Substantially Equivalent
Date received
2013-04-25
Decision date
2013-07-18
Days to decision
84 days
Clearance type
Special
Product code
DWA
Device class
2
Regulation number
870.4380
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Burlington, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
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PMA approvals by this applicant

RecordFirmDate
HEARTMATE XVE LVAS (P920014/S031)Thoratec Corp2011-12-21
THORATEC HEARTMATE XVE LVAS (P920014/S029)Thoratec Corp2009-03-13
HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM (P920014/S027)Thoratec Corp2007-06-29
HEARTMATE LVAS SYSTEM (P920014/S025)Thoratec Corp2005-03-22
THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P920014/S024)Thoratec Corp2005-02-02
THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P920014/S023)Thoratec Corp2004-07-08
HEARTMATE XVE LVAS (P920014/S019)Thoratec Corp2004-06-29
THORATEC HEARTMATE XVE AND VE LEST VENTRICULAR ASSIST SYSTEM (LVAS) (P920014/S022)Thoratec Corp2003-12-02