Auryon Atherectomy System

Catheter, Peripheral, Atherectomy

Eximo Medical Ltd.

The following data is part of a premarket notification filed by Eximo Medical Ltd. with the FDA for Auryon Atherectomy System.

Pre-market Notification Details

Device IDK221077
510k NumberK221077
Device Name:Auryon Atherectomy System
ClassificationCatheter, Peripheral, Atherectomy
Applicant Eximo Medical Ltd. Pekeris St 3 Rehovot,  IL 7670203
ContactYoel Zabar
CorrespondentJames Welsh
AngioDynamics 603 Queensbury Ave Queensbury,  NY  12804
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-12
Decision Date2022-06-09

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