
Medtronic, Inc.
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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 is an FDA 510(k)-cleared medical device (K191077) manufactured by Medtronic, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2019. Regulation: 8.

ADC
SKU DX606933

MDF
SKU DX683863

3M Littmann
SKU DX771242

Welch Allyn
SKU DX297280