Name: Predicase
Price: 199 USD

K-number	K160641
Device name	Solitaire Platinum Revascularization Device, 6x40 mm
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product code	NRY
Device class	Class II
Decision date	Mar 8, 2017
Decision	Substantially Equivalent
Regulation	870.1250

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Solitaire Platinum Revascularization Device, 6x40 mm

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