510(k) K180560

Sherlock 3CG+ T ip Confirmation System by C.R. Bard, Inc. — Product Code LJS

K180560 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Sherlock 3CG+ T ip Confirmation System". The FDA issued a decision of Substantially Equivalent on Jun 18, 2018. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. C.R. Bard, Inc. has 645 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 18, 2018
Date Received
Mar 1, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type
510(k)