K-number	K212784
Device name	TightRail Guardian Motorized Dilator Sheath
Applicant	Spectranetics, Inc.
Product code	DRE
Device class	Class II
Decision date	Aug 24, 2022
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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TightRail Guardian Motorized Dilator Sheath

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