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 | K142267 |
510k Number | K142267 |
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 | 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 | 2014-08-15 |
Decision Date | 2014-10-17 |
Summary: | summary |