The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Powerpicc Provena Catheters With Solo Valve Technology.
Device ID | K162441 |
510k Number | K162441 |
Device Name: | PowerPICC Provena Catheters With SOLO Valve Technology |
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 | 2016-08-31 |
Decision Date | 2017-04-24 |
Summary: | summary |