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FDA 510(k) Applications Submitted by Erika Huffman
FDA 510(k) Number
Submission Date
Device Name
Applicant
K200198
01/27/2020
WIRION
Cardiovascular Systems, Inc
K210282
02/01/2021
WIRION Embolic Protection System
Cardiovascular Systems Inc.
K211240
04/26/2021
ViperCross Support Catheters
Cardiovascular Systems, Inc.
K211251
04/26/2021
ViperCath XC Peripheral Exchange Catheter
Cardiovascular Systems, Inc.
K212725
08/27/2021
ViperCross Support Catheters
Cardiovascular Systems, Inc.
K183000
10/30/2018
ViperCath XC Peripheral Exchange Catheter
Cardiovascular Systems, Inc.
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