WIRION

Temporary Carotid Catheter For Embolic Capture

Cardiovascular Systems, Inc

The following data is part of a premarket notification filed by Cardiovascular Systems, Inc with the FDA for Wirion.

Pre-market Notification Details

Device IDK200198
510k NumberK200198
Device Name:WIRION
ClassificationTemporary Carotid Catheter For Embolic Capture
Applicant Cardiovascular Systems, Inc 1225 Old Hwy 8 NW Saint Paul,  MN  55112
ContactErika Huffman
CorrespondentErika Huffman
Cardiovascular Systems, Inc 1225 Old Hwy 8 NW Saint Paul,  MN  55112
Product CodeNTE  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-27
Decision Date2020-03-18

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