The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Sherlock 3cg+ T Ip Confirmation System.
Device ID | K180560 |
510k Number | K180560 |
Device Name: | Sherlock 3CG+ T Ip Confirmation System |
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 | Christopher M. Phillips |
Correspondent | Christopher M. Phillips 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 | 2018-03-01 |
Decision Date | 2018-06-18 |
Summary: | summary |