The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Powerpicc® Etoh Catheter And Powerpicc Solo®2 Etoh Catheter.
| Device ID | K151985 |
| 510k Number | K151985 |
| Device Name: | PowerPICC® EtOH Catheter And PowerPICC SOLO®2 EtOH 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 | Bryan Stone |
| Correspondent | Bryan Stone 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-17 |
| Decision Date | 2016-06-14 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() POWERPICC 78216794 2960842 Live/Registered |
C. R. Bard, Inc. 2003-02-20 |