Atlas FDA

CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005

FDA 510(k) clearance K092075 · decided 2009-08-07

Clearance details

K-number
K092075
Device name
CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
Applicant
St. Jude Medical, Cardiac Rhythm Management Divisi
Decision
Substantially Equivalent
Date received
2009-07-09
Decision date
2009-08-07
Days to decision
29 days
Clearance type
Special
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