meddevicedb.com FDA Device Reference

XplantR Explant Tool

DEN250033 Class II Direct
Decision Date
2026-04-17
Sponsor / Applicant
Hjarta Care, LLC

Technical Specification

510(k) Submission ID DEN250033
Product Code SHR
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.4520
Decision Date 2026-04-17
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

XplantR Explant Tool received FDA 510(k) clearance under submission number DEN250033, sponsored by Hjarta Care, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-04-17.

Classification & Regulation

This clearance is catalogued under FDA product code SHR and 21 CFR 870.4520, within the Cardiovascular review panel as a Class II device.