Question 1

Who is the manufacturer of XplantR Explant Tool?

Accepted Answer

Hjarta Care, LLC filed the De Novo classification request for XplantR Explant Tool (DEN250033).

Question 2

What is the FDA product code for XplantR Explant Tool?

Accepted Answer

SHR. in the CV panel.

Question 3

When was XplantR Explant Tool cleared by the FDA?

Accepted Answer

Apr 17, 2026 (decision: DENG).

Question 4

What is the regulatory pathway for XplantR Explant Tool?

Accepted Answer

De Novo classification (submission type: Direct).

Question 5

Who can help prepare an FDA De Novo submission like XplantR Explant Tool?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA De Novo submissions. See https://innolitics.com/services/regulatory/ or contact https://innolitics.com/contact.

Record ID	DEN250033
Device Name	XplantR Explant Tool
Applicant	Hjarta Care, LLC
Product Code	SHR · CV
Decision Date	Apr 17, 2026
Decision	DENG
Submission Type	Direct

XplantR Explant Tool

Device Facts