Home / 510(k) Clearances / K193663

510(k) K193663

FloPump 57mL Centrifugal Pump by International Biophysics Corporation — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2021
Date Received
December 31, 2019
Clearance Type
Traditional
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 International Biophysics Corporation

  • K170029 — FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile (December 15, 2017)
  • K122480 — INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST (March 27, 2013)

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)
  • 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)
  • K192850 — Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood (April 13, 2020)