FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX (K111485) — FDA 510(k) Clearance | Predicase

K-number	K111485
Device name	FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
Applicant	Boston Scientific Corporation
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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