510(k) K261399
- Device
- ELISIO™-HX
- Applicant
- Nipro Medical Corporation
- 510(k) number
- K261399
- Product code
- QAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-28
- Date received
- 2026-04-29
- Regulation
- 876.5862
- Classification name
- Hemodialyzer With Expanded Solute Removal Profile
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jessica Oswald-McLeod
- Address
- 3150 NW 107th Ave. Miami FL US 33172 33172
FDA Registration Numbers#
- 1056186
- 9610987
- 3038195011
- 3000247873
- 9611369
Source Documents#
Other 510(k) Records For Product Code QAX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | Baxter Healthcare Corporation | 2020-08-28 |