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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name laser-powered inferior vena cava filter retrieval catheter
De Novo Number DEN210024
Device Name CavaClear Laser Sheath
Requester
spectranetics, inc.
9965 federal drive
colorado springs,  CO  80921
Contact sondra chandler
Regulation Number870.5125
Classification Product Code
QRJ  
Date Received06/25/2021
Decision Date 12/21/2021
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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