The following data is part of a premarket notification filed by C.r. Bard, Inc with the FDA for Hickman Trifusion Catheter.
Device ID | K172511 |
510k Number | K172511 |
Device Name: | Hickman TriFusion 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 | Mona Shahrebani |
Correspondent | Mona Shahrebani 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 | 2017-08-21 |
Decision Date | 2018-04-20 |
Summary: | summary |