FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
K Number: DEN190042
·
Decision Aug 28, 2020
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
61
Review Days
347
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Basic Information
- Device Name
- Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
- K Number
- DEN190042
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.5862
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Baxter Healthcare Corporation
- Date Received
- September 16, 2019
- Decision Date
- August 28, 2020
- Product Code
- QAX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QAX | Hemodialyzer With Expanded Solute Removal Profile | FDA class 2 | Gastroenterology, Urology |
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