510(k) K190910
K190910 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PrisMax System Version 2". The FDA issued a decision of Substantially Equivalent on July 25, 2019. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2019
- Date Received
- April 8, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type