K-number	K111498
Device name	FATHOM (TM) 14 STEERABLE GUIDEWIRE
Applicant	Boston Scientific Corp
Product code	DQX
Device class	Class II
Decision date	Jun 30, 2011
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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FATHOM (TM) 14 STEERABLE GUIDEWIRE

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