The following data is part of a premarket notification filed by C.r Bard. Inc. with the FDA for Zenysis Short-term Dialysis Catheter.
| Device ID | K163458 |
| 510k Number | K163458 |
| Device Name: | Zenysis Short-Term Dialysis Catheter |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | C.R BARD. INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Silvia De La Barra |
| Correspondent | Silvia De La Barra C.R BARD. INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-12-09 |
| Decision Date | 2017-04-04 |
| Summary: | summary |