SOLCART B
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
B. BRAUN AVITUM AG
The following data is part of a premarket notification filed by B. Braun Avitum Ag with the FDA for Solcart B.
Pre-market Notification Details
| Device ID | K102194 |
| 510k Number | K102194 |
| Device Name: | SOLCART B |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | B. BRAUN AVITUM AG 901 MARCON BLVD. Allentown, PA 18109 |
| Contact | Angela Caravella |
| Correspondent | Angela Caravella B. BRAUN AVITUM AG 901 MARCON BLVD. Allentown, PA 18109 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-04 |
| Decision Date | 2011-04-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046963621599 | K102194 | 000 |
Trademark Results [SOLCART B]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLCART B 77194577 3713720 Live/Registered |
B.BRAUN AVITUM AG 2007-05-31 |
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