The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Sherlock 3cg Tip Positioning System Stylet.
Device ID | K172397 |
510k Number | K172397 |
Device Name: | Sherlock 3CG Tip Positioning System Stylet |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-08 |
Decision Date | 2017-09-29 |
Summary: | summary |