The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Niagara, Niagara Slim-cath, And Brevia Short-term Curved Extension Hemodialysis Catheters.
| Device ID | K090102 |
| 510k Number | K090102 |
| Device Name: | NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | C.R. BARD, INC. 605 N 5600 W Salt Lake City, UT 84116 |
| Contact | Jessica Agnello |
| Correspondent | Jessica Agnello C.R. BARD, INC. 605 N 5600 W Salt Lake City, UT 84116 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-01-15 |
| Decision Date | 2009-02-12 |
| Summary: | summary |