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510(k) K103250

CPS DIRECT SL II SLITTABLE OUTER CATHETER by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2011
Date Received
November 3, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by St. Jude Medical, Cardiac Rhythm Management Divisi

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  • K120298 — CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE (May 8, 2012)
  • K111943 — AGILLS PF DELIVERY SYSTEM (September 29, 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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