Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer

by Baxter Healthcare Corporation

De Novo DEN190042

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

in data synced 24 Oct 2026

Documents

De Novo DEN190042↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA De NovoDENG De Novo granted · Direct	NumberDEN190042	Date28 Aug 2020Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number: DEN190042
FDA Product Code: QAX

Device Class: Class II
Regulation: 21 CFR Part 876.5862
Advisory Committee: Gastroenterology, Urology
FDA Decision: DENG De Novo granted

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