DEN250033 - XplantR Explant Tool (FDA 510(k) Clearance)

DEN250033 is an FDA 510(k) submission (not cleared) for the XplantR Explant Tool.

Submitted by Hjarta Care, LLC (Waukesha, US). The FDA issued a Not Cleared (DENG) decision on April 17, 2026 after a review of 253 days.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 253 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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