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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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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
Classification Product Code
SHR
Date Received08/07/2025
Decision Date 04/17/2026
Decision granted (DENG)
Review Advisory Committee Cardiovascular
Type Direct
Predetermined Change
Control Plan Authorized		 No
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