Skip to content

Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor

by Medtronic, Inc.

510(k) K191077

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191077↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK191077 Date27 Aug 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 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 non-roller type cardiopulmonary bypass pump designed for use in cardiac surgical procedures. It employs centrifugal force to circulate blood, providing controlled and continuous flow during open-heart surgeries, ensuring oxygenation and perfusion of vital organs.

This device is supplied as a reusable system, intended for use in sterile operating room environments. It includes multiple surface variants (standard, Balance Biosurface, Cortive BioActive Surface) and requires pairing with the Medtronic External Drive Motor for operation. Regulated under FDA 510(k) clearance and MDR, it adheres to Class II medical device standards (870.4360) and is classified under cardiovascular specialty. Device registration numbers and FEI identifiers are provided for compliance tracking.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Questions

AI-generated answers, 18 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 types of surgical procedures is the Affinity CP Centrifugal Blood Pump designed for, and how does it function during those procedures?

    The Affinity CP Centrifugal Blood Pump is specifically designed for use in cardiac surgical procedures, particularly those requiring cardiopulmonary bypass. It employs centrifugal force to circulate blood continuously and controllably during open-heart surgeries, ensuring oxygenation and perfusion of vital organs. This makes it ideal for procedures like coronary artery bypass grafting (CABG), valve replacements, or other complex cardiac interventions where temporary circulatory support is required.

  • Is the Affinity CP Centrifugal Blood Pump intended for single-use or reusable applications, and how should it be handled in the operating room?

    The Affinity CP Centrifugal Blood Pump is supplied as a reusable system, meaning it is intended for use in sterile operating room environments after proper cleaning, disinfection, and sterilization. It must be handled according to established reprocessing protocols to maintain safety and functionality for subsequent procedures. The device requires pairing with the Medtronic External Drive Motor for operation.

  • What surface variants are available for the Affinity CP Centrifugal Blood Pump, and how might they influence clinical decision-making?

    The Affinity CP Centrifugal Blood Pump is available in three surface variants: the standard version, the Balance Biosurface, and the Cortive BioActive Surface. These variants may influence clinical decision-making based on factors like hemocompatibility (how well the blood interacts with the surface) and risk of thrombosis or hemolysis. The Balance Biosurface and Cortive BioActive Surface are designed to potentially reduce blood damage and improve patient outcomes compared to the standard version.

  • How is the regulatory status of the Affinity CP Centrifugal Blood Pump defined, and what does this mean for healthcare providers?

    The Affinity CP Centrifugal Blood Pump is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), adhering to Class II medical device standards (870.4360). This classification means it has undergone rigorous evaluation by regulatory bodies to ensure safety and effectiveness for its intended use in cardiopulmonary bypass procedures. Healthcare providers can rely on its compliance with these standards, though they should always follow manufacturer guidelines and institutional protocols for proper use.

  • What are the key differences between the Affinity CP Centrifugal Blood Pump and the Medtronic External Drive Motor, and how do they work together?

    The Affinity CP Centrifugal Blood Pump is the actual device that circulates blood using centrifugal force, while the Medtronic External Drive Motor is a separate component that powers and controls the pump during surgery. The pump and motor are intended to be used together, with the motor providing the necessary rotational energy to drive the pump’s impeller. This pairing ensures precise flow control and reliability during cardiopulmonary bypass procedures.