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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 device for open surgical explant of endovascular prostheses
De Novo Number DEN250033
Device Name XplantR Explant Tool
Requester
hjarta care, llc
n16 w23233 stone ridge dr.
suite 200
waukesha,  WI  53188
Contact brian thorson
Regulation Number870.4520
Classification Product Code
SHR  
Date Received08/07/2025
Decision Date 04/17/2026
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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