PrismaSATE
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Baxter Healthcare Corporation
The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Prismasate.
Pre-market Notification Details
| Device ID | K162887 |
| 510k Number | K162887 |
| Device Name: | PrismaSATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | Baxter Healthcare Corporation 32650 North Wilson Road Round Lake, IL 60073 |
| Contact | Kristen Bozzelli |
| Correspondent | Kristen Bozzelli Baxter Healthcare Corporation 32650 North Wilson Road Round Lake, IL 60073 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2017-01-06 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414123094 | K162887 | 000 |
Trademark Results [PrismaSATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRISMASATE 78032988 2670296 Live/Registered |
GAMBRO RENAL PRODUCTS, INC. 2000-10-30 |
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