The following data is part of a premarket notification filed by Baxter Healthcare with the FDA for Minicap Extended Life Pd Transfer Sets.
| Device ID | K192705 |
| 510k Number | K192705 |
| Device Name: | MiniCap Extended Life PD Transfer Sets |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | Baxter Healthcare 32650 N. Wilson Road Round Lake, IL 60073 |
| Contact | Kimberly Garcia |
| Correspondent | Kimberly Garcia Baxter Healthcare 32650 N. Wilson Road Round Lake, IL 60073 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2019-10-25 |
| Summary: | summary |