Home / 510(k) Clearances / K030462

510(k) K030462

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 by Cobe Cardiovascular, Inc. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2003
Date Received
February 12, 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 Cobe Cardiovascular, Inc.

  • K050111 — SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG (March 8, 2005)
  • K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (November 19, 2004)
  • K040184 — DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER (February 26, 2004)
  • K033641 — SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 (December 11, 2003)
  • K021830 — SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM (July 2, 2002)
  • K011835 — COBE REVOLUTION (February 12, 2002)
  • K013480 — COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (November 16, 2001)
  • K012763 — SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM (November 15, 2001)
  • K001509 — STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE (October 26, 2001)
  • K012898 — MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM (September 17, 2001)

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)