PrisMax Control Unit
510(k) K163530
PrisMax Control Unit is a medical device (FDA Class II; FDA product code KDI, Dialyzer, High Permeability With Or Without Sealed Dialysate System) made by Baxter Healthcare Corp, cleared under FDA 510(k) K163530 on 3 May 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK163530 | Date3 May 2017 | StatusActive |
Official records
- FDA 510(k) database K163530
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KDI
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5860
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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