The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Flexicap Disconnect Cap With Povidone-iodine Solution, Minicap With Povidone-iodine Solution.
| Device ID | K152129 |
| 510k Number | K152129 |
| Device Name: | FlexiCap Disconnect Cap With Povidone-Iodine Solution, MiniCap With Povidone-Iodine Solution |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake, IL 60073 |
| Contact | Tiffany Lin |
| Correspondent | Tiffany Lin BAXTER HEALTHCARE CORPORATION 32650 N. WILSON ROAD Round Lake, IL 60073 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-31 |
| Decision Date | 2015-10-29 |
| Summary: | summary |