Atlas FDA

CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER

FDA 510(k) clearance K120296 · decided 2012-05-11

Clearance details

K-number
K120296
Device name
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
Decision
Substantially Equivalent
Date received
2012-01-31
Decision date
2012-05-11
Days to decision
101 days
Clearance type
Traditional
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Sylmar, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
META AND TEMPO PACEMAKERS (P900070/S030)St. Jude Medical, Cardiac Rhythm Management Divisi2006-07-28
META & TEMPO PACEMAKERS (P900070/S034)St. Jude Medical, Cardiac Rhythm Management Divisi2006-07-11
META AND TEMPO PACEMAKERS (P900070/S032)St. Jude Medical, Cardiac Rhythm Management Divisi2006-04-28
META AND TEMPO PACEMAKERS (P900070/S031)St. Jude Medical, Cardiac Rhythm Management Divisi2006-03-14
APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A) (P900070/S028)St. Jude Medical, Cardiac Rhythm Management Divisi2003-01-22
TRILOGY/SOLUS II/PARAGON III/PHOENIX III (P900070/S027)St. Jude Medical, Cardiac Rhythm Management Divisi2000-09-07
TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ ADDVENT TEMPO (P900070/S026)St. Jude Medical, Cardiac Rhythm Management Divisi2000-02-18
R5.111WE(REVISION OF R5.85WE) (P900070/S025)St. Jude Medical, Cardiac Rhythm Management Divisi1999-09-24