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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K211251
Device Name ViperCath XC Peripheral Exchange Catheter
Applicant
Cardiovascular Systems, Inc.
1225 Old Hwy 8 NW
St. Paul,  MN  55112
Applicant Contact Erika Huffman
Correspondent
Cardiovascular Systems, Inc.
1225 Old Hwy 8 NW
St. Paul,  MN  55112
Correspondent Contact Erika Huffman
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/26/2021
Decision Date 05/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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