ViperCath XC Peripheral Exchange Catheter

Catheter, Percutaneous

Cardiovascular Systems, Inc.

The following data is part of a premarket notification filed by Cardiovascular Systems, Inc. with the FDA for Vipercath Xc Peripheral Exchange Catheter.

Pre-market Notification Details

Device IDK211251
510k NumberK211251
Device Name:ViperCath XC Peripheral Exchange Catheter
ClassificationCatheter, Percutaneous
Applicant Cardiovascular Systems, Inc. 1225 Old Hwy 8 NW St. Paul,  MN  55112
ContactErika Huffman
CorrespondentErika Huffman
Cardiovascular Systems, Inc. 1225 Old Hwy 8 NW St. Paul,  MN  55112
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-05-26

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