510(k) K172397

Sherlock 3CG Tip Positioning System Stylet by C.R. Bard, Inc. — Product Code LJS

K172397 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Sherlock 3CG Tip Positioning System Stylet". The FDA issued a decision of Substantially Equivalent on Sep 29, 2017. 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
Sep 29, 2017
Date Received
Aug 8, 2017
Clearance Type
Special
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)