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Affinity Cp Centrifugal Pump, Resting Heart Sys., Myotherm Cardioplegia Deliv., Affinity Hollow Fiber Oxygenator, Aaf

by Medtronic, Inc.

510(k) K111972

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 NumberK111972 Date27 Jul 2011ClearedStatusActive

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  • Withdrawn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)

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, 6 Oct 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 Pump is a blood pump designed for cardiopulmonary bypass procedures. It features a low prime design with smooth cone and low-profile fins to gently handle blood and minimize hemolysis. The device is part of a system that includes the Myotherm Cardioplegia Delivery and Affinity Hollow Fiber Oxygenator components.

This device is intended for use in extracorporeal perfusion circuits to oxygenate and remove carbon dioxide from blood, and to cool or warm blood during cardiopulmonary bypass procedures up to 6 hours. It is supplied as part of a system and has received FDA 510(k) clearance with the product code KFM. The device is classified under cardiovascular medical specialty and is regulated under 870.4360.

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Questions

AI-generated answers, 6 Oct 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 Pump used for?

    The Affinity CP Centrifugal Pump is designed for cardiopulmonary bypass procedures. It is part of a system that includes the Myotherm Cardioplegia Delivery and Affinity Hollow Fiber Oxygenator components, used to oxygenate and remove carbon dioxide from blood, and to cool or warm blood during procedures up to 6 hours.

  • How is the Affinity CP Centrifugal Pump supplied?

    The device is supplied as part of a system that includes the Myotherm Cardioplegia Delivery and Affinity Hollow Fiber Oxygenator components. It is not supplied individually but as part of a complete extracorporeal perfusion circuit system.

  • What are the key features of the Affinity CP Centrifugal Pump?

    The pump features a low prime design with smooth cone and low-profile fins to gently handle blood and minimize hemolysis. It is designed for use in extracorporeal perfusion circuits during cardiopulmonary bypass procedures up to 6 hours.

  • What is the regulatory status of the Affinity CP Centrifugal Pump?

    The device has received FDA 510(k) clearance with the product code KFM. It is classified under cardiovascular medical specialty and is regulated under 870.4360. The clearance was granted on July 27, 2011.