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 | K153190 |
510k Number | K153190 |
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 (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-03 |
Decision Date | 2016-01-05 |
Summary: | summary |