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510(k) K043323

D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR by Dideco S.R.L. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2005
Date Received
December 2, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

Other clearances by Dideco S.R.L.

  • K052717 — D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER (October 20, 2005)
  • K051232 — D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDI (May 20, 2005)
  • K050890 — ECC.O SYSTEM (May 5, 2005)
  • K050447 — PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (March 8, 2005)
  • K041061 — D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS (May 6, 2004)
  • K033323 — D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HO (January 13, 2004)
  • K033987 — D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS (January 8, 2004)
  • K033714 — MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COAT (December 11, 2003)
  • K032040 — IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, (July 9, 2003)
  • K031223 — SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR (May 2, 2003)

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