Atlas FDA

Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer

FDA 510(k) clearance DEN190042 · decided 2020-08-28

Clearance details

K-number
DEN190042
Device name
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
Applicant
Baxter Healthcare Corporation
Decision
Unknown
Date received
2019-09-16
Decision date
2020-08-28
Days to decision
347 days
Clearance type
Direct
Product code
QAX
Device class
2
Regulation number
876.5862
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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