510(k) DEN190042
- Device
- Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
- Applicant
- Baxter Healthcare Corporation
- 510(k) number
- DEN190042
- Product code
- QAX
- Decision
- Unknown (DENG)
- Decision date
- 2020-08-28
- Date received
- 2019-09-16
- Regulation
- 876.5862
- Classification name
- Hemodialyzer With Expanded Solute Removal Profile
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kristen Bozzelli
- Address
- 32650 N. Wilson Rd. Round Lake IL US 60073 60073
FDA Registration Numbers#
- 3038195011
- 9611369
Source Documents#
510(k) summary PDF not indicated by FDA