TightRail Guardian Motorized 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 Guardian Motorized Dilator Sheath.

Pre-market Notification Details

Device IDK212784
510k NumberK212784
Device Name:TightRail Guardian Motorized Dilator Sheath
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant Spectranetics, Inc. 9965 Federal Drive Colorado Springs,  CO  80921
ContactJordan Baum
CorrespondentJordan Baum
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 Received2021-09-01
Decision Date2022-08-24

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