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510(k) K122090

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code MXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2012
Date Received
July 16, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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  • K111943 — AGILLS PF DELIVERY SYSTEM (September 29, 2011)
  • K103250 — CPS DIRECT SL II SLITTABLE OUTER CATHETER (January 19, 2011)
  • K093858 — PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A (April 2, 2010)
  • K092075 — CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2 (August 7, 2009)
  • K090613 — CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, (July 1, 2009)
  • K080924 — MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (April 30, 2008)
  • K072864 — ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (March 13, 2008)

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  • K173232 — myMerlin(TM) Mobile Application Model APP1001 (November 2, 2017)
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