K-number	DEN190038
Device name	Surfacer Inside-Out Access Catheter System
Applicant	Bluegrass Vascular Technologies, Inc.
Product code	QJH
Device class	Class II
Decision date	Feb 10, 2020
Decision	Not Substantially Equivalent
Regulation	870.1342

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Source

View the full FDA submission: accessdata.fda.gov

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Surfacer Inside-Out Access Catheter System

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