Home / 510(k) Clearances / K983272

510(k) K983272

IBC FLOPUMP, MODEL 6000 by International Biophysics Corp. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1999
Date Received
September 17, 1998
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 Corp.

  • K072688 — LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 (January 11, 2008)
  • K030181 — INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM (April 17, 2003)
  • K992657 — IBC VRV, MODEL 1350 (February 18, 2000)
  • K992785 — IBC FLOGUARD, MODEL 6050 (January 14, 2000)
  • K992964 — IBC VENT VALVE, MODEL 1400 (November 19, 1999)
  • K963703 — ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) (April 8, 1998)
  • K963756 — IBC CARDIAC SUCTION WARD (November 14, 1997)
  • K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (March 20, 1997)
  • K955379 — IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) (May 14, 1996)
  • K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) (May 14, 1996)

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)