Sentrant Introducer Sheath With Hydrophilic Coating

Introducer, Catheter

Medtronic Vascular, Inc.

The following data is part of a premarket notification filed by Medtronic Vascular, Inc. with the FDA for Sentrant Introducer Sheath With Hydrophilic Coating.

Pre-market Notification Details

Device IDK171866
510k NumberK171866
Device Name:Sentrant Introducer Sheath With Hydrophilic Coating
ClassificationIntroducer, Catheter
Applicant Medtronic Vascular, Inc. 3576 Unocal Place Santa Rosa,  CA  95403
ContactWee Wen Leow
CorrespondentWee Wen Leow
Medtronic Vascular, Inc. 3576 Unocal Place Santa Rosa,  CA  95403
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-22
Decision Date2017-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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