TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath

Dilator, Vessel, For Percutaneous Catheterization

SPECTRANETICS, INC.

The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Tightrail Rotating Dilator Sheath/tightrail Mini Dilator Sheath.

Pre-market Notification Details

Device IDK142546
510k NumberK142546
Device Name:TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs,  CO  80921
ContactChristopher Mclellan
CorrespondentChristopher Mclellan
SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs,  CO  80921
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-10
Decision Date2014-09-25
Summary:summary

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