Sherlock 3CG Tip Positioning System Stylet

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

C.R.Bard, Inc.

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.

Pre-market Notification Details

Device IDK142267
510k NumberK142267
Device Name:Sherlock 3CG Tip Positioning System Stylet
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant C.R.Bard, Inc. 605 North 5600 West Salt Lake City,  UT  84116
ContactBryan Stone
CorrespondentBryan Stone
C.R.Bard, Inc. 605 North 5600 West Salt Lake City,  UT  84116
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-15
Decision Date2014-10-17
Summary:summary

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