The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Niagara Slim-cath.
| Device ID | K010778 |
| 510k Number | K010778 |
| Device Name: | NIAGARA SLIM-CATH |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Peggy Keiffer |
| Correspondent | Peggy Keiffer C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-15 |
| Decision Date | 2001-04-13 |