The following data is part of a De Novo classification by Baxter Healthcare Corporation with the FDA for Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer.
| DeNovo ID | DEN190042 |
| Device Name: | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer |
| Classification | Hemodialyzer With Expanded Solute Removal Profile |
| Applicant | Baxter Healthcare Corporation 32650 North Wilson Road Round Lake, IL 60073 |
| Contact | Kristen Bozzelli |
| Product Code | QAX |
| CFR Regulation Number | 876.5862 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2019-09-16 |
| Decision Date | 2020-08-28 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414125715 | DEN190042 | 000 |
| 37332414125722 | DEN190042 | 000 |