K-number	K062446
Device name	MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
Applicant	Terumo Medical Corp.
Product code	DYB
Device class	Class II
Decision date	Oct 23, 2006
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH

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