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 IDK172397
510k NumberK172397
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
ContactMona Shahrebani
CorrespondentMona Shahrebani
C.R. Bard, Inc. 605 North 5600 West Salt Lake City,  UT  84116
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-08
Decision Date2017-09-29
Summary:summary

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