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Affinity NT Oxygenator with Cortiva BioActive Surface

by Medtronic, Inc.

510(k) K162016

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 · Traditional NumberK162016 Date21 Sep 2016ClearedStatusActive

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  • Withdrawn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
DTZ
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 NT Oxygenator with Cortiva BioActive Surface is a cardiopulmonary bypass oxygenator designed for gas exchange during extracorporeal circulation. It facilitates oxygenation and carbon dioxide removal from blood, supporting hemodynamic stability during surgical procedures requiring temporary circulatory assistance. The device incorporates a radial flow design to optimize efficiency and performance in blood oxygenation.

This single-use, non-sterile device is intended for use in controlled clinical settings such as operating rooms or cardiac catheterization labs. It is supplied as a disposable component and requires proper priming and connection to a cardiopulmonary bypass circuit. The Cortiva BioActive Surface is engineered to minimize inflammatory responses and enhance biocompatibility. The device is classified under FDA regulation number 870.4350 and holds a 510(k) clearance (K162016) for traditional review in the cardiovascular category.

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Questions

AI-generated answers, 1 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 NT Oxygenator with Cortiva BioActive Surface used for?

    This device is designed for gas exchange during extracorporeal circulation, specifically oxygenating blood and removing carbon dioxide to support hemodynamic stability during surgical procedures requiring temporary circulatory assistance, such as open-heart surgeries or cardiac catheterizations.

  • Is the Affinity NT Oxygenator with Cortiva BioActive Surface sterile?

    No, the Affinity NT Oxygenator with Cortiva BioActive Surface is supplied as a non-sterile, single-use disposable component. It must be sterilized by the user prior to use in a controlled clinical setting, such as an operating room or cardiac catheterization lab.

  • How does the Cortiva BioActive Surface enhance performance?

    The Cortiva BioActive Surface is engineered to minimize inflammatory responses and enhance biocompatibility, which helps reduce adverse reactions during blood contact and improves overall performance in oxygenation efficiency.

  • What type of priming and setup is required for this device?

    The Affinity NT Oxygenator requires proper priming and connection to a cardiopulmonary bypass circuit before use. Priming involves filling the device with a compatible fluid to ensure proper function and prevent air embolism during surgery.

  • What regulatory pathway does this device follow?

    The Affinity NT Oxygenator with Cortiva BioActive Surface is classified under FDA regulation number 870.4350 and holds a 510(k) clearance (K162016) for traditional review in the cardiovascular category, demonstrating substantial equivalence to a predicate device.