K-number	K111252
Device name	ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
Applicant	Boston Scientific Corp
Product code	DQY
Device class	Class II
Decision date	Jun 2, 2011
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F

Everything you need for a 510(k) submission. Nothing you don't.