K-number	K162181
Device name	Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
Applicant	Cardiacassist, Inc.
Product code	DRE
Device class	Class II
Decision date	Jan 6, 2017
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

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