The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Power-trialysis Short-term Dialysis Catheter.
| Device ID | K133456 |
| 510k Number | K133456 |
| Device Name: | POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| Applicant | C.R. BARD, INC. 605 N 5600 W Salt Lake City, UT 84116 |
| Contact | Elizabeth Peterson |
| Correspondent | Elizabeth Peterson C.R. BARD, INC. 605 N 5600 W Salt Lake City, UT 84116 |
| Product Code | NIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2014-09-24 |
| Summary: | summary |