Tigereye CTO-Crossing Catheter

Catheter For Crossing Total Occlusions

Avinger, Inc.

The following data is part of a premarket notification filed by Avinger, Inc. with the FDA for Tigereye Cto-crossing Catheter.

Pre-market Notification Details

Device IDK201330
510k NumberK201330
Device Name:Tigereye CTO-Crossing Catheter
ClassificationCatheter For Crossing Total Occlusions
Applicant Avinger, Inc. 400 Chesapeake Drive Redwood City,  CA  94063
ContactThomas Lawson
CorrespondentThomas Lawson
Avinger, Inc. 400 Chesapeake Drive Redwood City,  CA  94063
Product CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-19
Decision Date2020-09-10

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