Home / 510(k) Clearances / K032040

510(k) K032040

IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR by Dideco S.P.A. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2003
Date Received
July 1, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

Other clearances by Dideco S.P.A.

  • 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)
  • K043323 — D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RE (February 1, 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)
  • K031223 — SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR (May 2, 2003)

Other clearances for product code KFM

  • K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-N (August 4, 2025)
  • K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-N (June 24, 2025)
  • K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT) (October 26, 2023)
  • K232132 — LifeSPARC System (August 3, 2023)
  • K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum P (May 19, 2023)
  • K200091 — Capiox iCP Centrifugal Pump (November 18, 2021)
  • K201320 — Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor (November 3, 2021)
  • K193663 — FloPump 57mL Centrifugal Pump (March 10, 2021)
  • K202169 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood (September 2, 2020)
  • K201068 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Bala (May 21, 2020)