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Affinity CP Centrifugal Blood Pump

by Medtronic, Inc.

510(k) K201068

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK201068 Date21 May 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
510(k) Number
FDA Product Code
KFM
Device Class
Class II
Regulation
21 CFR Part 870.4360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Affinity CP Centrifugal Blood Pump is a medical device designed to facilitate extracorporeal circulation during cardiac surgeries. It utilizes centrifugal force to propel blood through the circuit, minimizing shear stress and reducing the risk of hemolysis. The device is available with different surface coatings, including Balance Biosurface and Cortiva BioActive Surface.

The device is supplied with a low prime volume and is designed for use with specific pump speed controllers and remote drives. It is classified as a Class 2 device with the product code KFM and is regulated under 870.4360. The device has been cleared by the FDA under the 510K clearance type, with the decision code SESE, and is manufactured by Medtronic, Inc.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Affinity CP Centrifugal Blood Pump used for?

    The Affinity CP Centrifugal Blood Pump is used to facilitate extracorporeal circulation during cardiac surgeries, utilizing centrifugal force to propel blood through the circuit.

  • What surface coatings are available for the Affinity CP Centrifugal Blood Pump?

    The device is available with different surface coatings, including Balance Biosurface and Cortiva BioActive Surface, to reduce the risk of hemolysis and improve biocompatibility.

  • Is the Affinity CP Centrifugal Blood Pump a single-use or reusable device?

    The description does not explicitly state whether the Affinity CP Centrifugal Blood Pump is single-use or reusable, but it is classified as a Class 2 device and has specific regulatory clearances.

  • What is the regulatory classification of the Affinity CP Centrifugal Blood Pump?

    The Affinity CP Centrifugal Blood Pump is classified as a Class 2 device with the product code KFM and is regulated under 870.4360, with FDA 510K clearance.