K-number	DEN250033
Device name	XplantR Explant Tool
Applicant	Hjarta Care, LLC
Product code	SHR
Device class	Class II
Decision date	Apr 17, 2026
Decision	Not Substantially Equivalent
Regulation	—

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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XplantR Explant Tool

Everything you need for a 510(k) submission. Nothing you don't.