K-number	K060418
Device name	8F SHERPA NX GUIDE CATHETER
Applicant	Medtronic Vascular
Product code	DQY
Device class	Class II
Decision date	Mar 15, 2006
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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8F SHERPA NX GUIDE CATHETER

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