Name: Predicase
Price: 199 USD

K-number	K101955
Device name	ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
Applicant	St Jude Medical
Product code	DRF
Device class	Class II
Decision date	Oct 15, 2010
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058

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