Name: Predicase
Price: 199 USD

K-number	K193576
Device name	Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product code	POL
Device class	Class II
Decision date	Nov 20, 2020
Decision	Substantially Equivalent
Regulation	882.5600

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)

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