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 |