Name: Predicase
Price: 199 USD

K-number	K191419
Device name	Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
Applicant	Rex Medical, L.P.
Product code	MCW
Device class	Class II
Decision date	Sep 12, 2019
Decision	Substantially Equivalent
Regulation	870.4875

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire

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