ViperCross Support Catheters

Catheter, Percutaneous

Cardiovascular Systems, Inc.

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

Pre-market Notification Details

Device IDK212725
510k NumberK212725
Device Name:ViperCross Support Catheters
ClassificationCatheter, Percutaneous
Applicant Cardiovascular Systems, Inc. 1225 Old Highway 8 NW St. Paul,  MN  55112
ContactErika Huffman
CorrespondentJonathan Holmes
Biomerics 6030 W. Harold Gatty Dr. Salt Lake City,  UT  84116
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-27
Decision Date2021-09-24

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