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Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer

DEN190042 Class II Direct
Decision Date
2020-08-28
Sponsor / Applicant
Baxter Healthcare Corporation

Technical Specification

510(k) Submission ID DEN190042
Product Code QAX
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5862
Decision Date 2020-08-28
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer received FDA 510(k) clearance under submission number DEN190042, sponsored by Baxter Healthcare Corporation. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-08-28.

Classification & Regulation

This clearance is catalogued under FDA product code QAX and 21 CFR 876.5862, within the Gastroenterology, Urology review panel as a Class II device.