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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / DEN250033

510(k) cleared

XplantR Explant Tool

Hjarta Care, LLC · Apr 17, 2026 · DEN250033

FDA cleared the XplantR Explant Tool from Hjarta Care, LLC on Apr 17, 2026 under DEN250033, a direct 510(k). The device falls under product code SHR, Device For Open Surgical Explant Of Endovascular Prostheses, regulated at 21 CFR 870.4520 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 7, 2025. The decision came 253 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hjarta Care, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250033?

DEN250033 is the FDA 510(k) for XplantR Explant Tool, submitted by Hjarta Care, LLC. FDA's decision date was Apr 17, 2026, under product code SHR (Device For Open Surgical Explant Of Endovascular Prostheses).

Who makes the XplantR Explant Tool?

Hjarta Care, LLC, based in Waukesha, WI, is the applicant of record for DEN250033.

How long did the DEN250033 review take?

FDA received the submission on Aug 7, 2025 and issued its decision on Apr 17, 2026, 253 days later.

← All decisions in April 2026