PrisMax System Version 3
FDA 510(k) K193482 · Baxter Healthcare Corporation
510(k) numberK193482
Submission
- Device name
- PrisMax System Version 3
- Applicant
- Baxter Healthcare Corporation
Brooklyn Park, MN, US - Received
- December 17, 2019
- Decision date
- March 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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Questions and answers
When was PrisMax System Version 3 cleared by the FDA?
PrisMax System Version 3 (K193482) received a 510(k) decision of Substantially Equivalent on March 13, 2020, 87 days after the submission was received.
What is the product code of K193482?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.