K-number	K142379
Device name	Passeo-35 PTA Catheter
Applicant	Biotronik, Inc.
Product code	LIT
Device class	Class II
Decision date	Dec 5, 2014
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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Passeo-35 PTA Catheter

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