The following data is part of a premarket notification filed by Baxter Healthcare with the FDA for Extended Life Capd Transfer Set, Peritoneal Dialysis Titanium Catheter Adapter And Locking Cap For Titanium Catheter Adapter.
| Device ID | K152675 |
| 510k Number | K152675 |
| Device Name: | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | BAXTER HEALTHCARE 32650 N. WILSON ROAD Round Lake, IL 60073 |
| Contact | John Lamela |
| Correspondent | John Lamela BAXTER HEALTHCARE 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 | 2015-09-18 |
| Decision Date | 2015-10-29 |
| Summary: | summary |