The following data is part of a premarket notification filed by C.r. Bard, Inc (bard Has Joined Bd) with the FDA for 3f Single Lumen And 4f Dual Lumen Powerpicc Provena Catherers; 3f Single Lumen And 4f Dual Lumen Powerpicc Provena Catherters With Solo Valve Technology.
| Device ID | K180548 |
| 510k Number | K180548 |
| Device Name: | 3F Single Lumen And 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen And 4F Dual Lumen PowerPICC Provena Catherters With SOLO Valve Technology |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | C.R. Bard, Inc (Bard Has Joined BD) 605 North 5600 West Salt Lake City, UT 84116 |
| Contact | Bryan Stone |
| Correspondent | Bryan Stone C.R. Bard, Inc (Bard Has Joined BD) 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 | 2018-03-01 |
| Decision Date | 2018-04-26 |
| Summary: | summary |