K-number	K183174
Device name	FlexCath Advance Steerable Sheath and Dilator
Applicant	Medtronic Cryocath, LP
Product code	DRA
Device class	Class II
Decision date	Nov 26, 2018
Decision	Substantially Equivalent
Regulation	870.1280

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Source

View the full FDA submission: accessdata.fda.gov

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FlexCath Advance Steerable Sheath and Dilator

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