The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for 6f Triple Lumen Powerline Central Venous Catheter, 5f Dual Lumen Powerline Central Venous Catheter.
| Device ID | K093927 |
| 510k Number | K093927 |
| Device Name: | 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Sarabjyot Mankoo |
| Correspondent | Sarabjyot Mankoo C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-02-04 |
| Summary: | summary |