The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Power-trialysis Triple Lumen Acute Dialysis Catheter.
| Device ID | K083675 |
| 510k Number | K083675 |
| Device Name: | POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Jessica Agnello |
| Correspondent | Jessica Agnello C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | NIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-12-11 |
| Decision Date | 2009-03-19 |
| Summary: | summary |