Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Oxygenator, Cardiopulmonary Bypass

FDA product code DTZ · 241 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.4350
Review panel
CV
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
1976-11-12 – 2026-09-14
DTZ 2019-05-17

Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac

Applicant Medtronic, Inc.

K number K191029

View details →
↑