The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for The Sherlock 3cg Tip Confirmation System (tcs).
Device ID | K140345 |
510k Number | K140345 |
Device Name: | THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) |
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 | James R Davis |
Correspondent | James R Davis 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 | 2014-02-11 |
Decision Date | 2014-03-14 |
Summary: | summary |