Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
510(k) K143073
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143073 | Date25 Mar 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
The Affinity NT Oxygenator is a Cardiopulmonary Bypass Oxygenator (Device Type: DTZ) designed for extracorporeal perfusion circuits. It facilitates efficient gas exchange—oxygenating blood and removing carbon dioxide—during cardiopulmonary bypass procedures, supporting circulatory support in cardiac surgery. The device incorporates a radial flow design to optimize performance and ensure consistent oxygen transfer.
This single-use, non-sterile device is intended for use in controlled clinical settings such as operating rooms or cardiac catheterization labs. It is available in multiple configurations, including versions with Trillium or Carmeda Biosurface coatings, and is regulated under FDA 510(k) clearance (K143073). The device adheres to regulatory standards for Class II medical devices (870.4350) and is supplied as part of a disposable extracorporeal circuit for procedures up to six hours in duration.
Other devices from Medtronic, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Affinity NT Oxygenator used for?
The Affinity NT Oxygenator is designed for extracorporeal perfusion circuits during cardiopulmonary bypass procedures in cardiac surgery. It facilitates oxygenation of blood and removal of carbon dioxide, ensuring stable circulatory support while the heart is temporarily stopped or bypassed. Its radial flow design enhances performance and consistency in gas exchange.
Is the Affinity NT Oxygenator sterile and single-use?
The Affinity NT Oxygenator is supplied as a non-sterile, single-use device. It must be sterilized by the facility prior to use in controlled clinical settings like operating rooms or cardiac catheterization labs. This ensures compliance with surgical standards and prevents contamination during procedures.
What biosurface options are available for the Affinity NT Oxygenator?
The Affinity NT Oxygenator is available in three configurations: the standard version, a version with Trillium Biosurface, and a version with Carmeda Biosurface. These coatings reduce thrombogenicity and improve biocompatibility, supporting longer procedural durations (up to six hours) without compromising performance.
How is the Affinity NT Oxygenator supplied, and what are its procedural limitations?
The device is supplied as part of a disposable extracorporeal circuit, ready for immediate use in cardiopulmonary bypass procedures. It is intended for procedures lasting up to six hours, after which it should be discarded. The radial flow design ensures consistent oxygen transfer, making it suitable for complex cardiac surgeries requiring extended bypass times.
What regulatory clearance does the Affinity NT Oxygenator hold?
The Affinity NT Oxygenator, including its biosurface variants, holds FDA 510(k) clearance (K143073) under the classification of Class II medical devices (product code DTZ). This clearance confirms its substantial equivalence to a legally marketed predicate device and compliance with U.S. regulatory standards for extracorporeal perfusion systems.