The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Sherlock 3cg® Tip Positioning System (tps) Stylet/t-lock Assembly.
Device ID | K222232 |
510k Number | K222232 |
Device Name: | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 |
Contact | Teresa Do-McCage |
Correspondent | Teresa Do-McCage Bard Access Systems, 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 | 2022-07-25 |
Decision Date | 2022-08-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SHERLOCK 3CG 77919581 4032247 Live/Registered |
C. R. Bard, Inc. 2010-01-25 |
SHERLOCK 3CG 77653777 3948257 Live/Registered |
C. R. Bard, Inc. 2009-01-21 |