The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for 15l Cycler Drainage Bag.
| Device ID | K214016 |
| 510k Number | K214016 |
| Device Name: | 15L Cycler Drainage Bag |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
| Contact | Maninee Patel |
| Correspondent | Maninee Patel Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-22 |
| Decision Date | 2022-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412722899 | K214016 | 000 |