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Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 Directory / Cardiovascular

Cardiovascular

Inquis Medical

Menlo Park, CA · Series C · 510(k) cleared

Inquis Medical makes the Aventus aspiration thrombectomy system with blood reinfusion and tissue sensing for deep vein thrombosis and pulmonary embolism.

FDA DECISIONS ON FILE

4 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jul 27, 26	K261105510(k)	Powered Aventus Thrombectomy System	Inquis Medical	Cardiovascular	QEZ
Jul 15, 26	K262030510(k)	Aventus Thrombectomy System	Inquis Medical	Cardiovascular	QEZ
Apr 13, 26	K260091510(k)	Aventus Introducer Sheath	Inquis Medical	Cardiovascular	DYB
Jan 15, 26	K253925510(k)	Aventus Thrombectomy System	Inquis Medical	Cardiovascular	QEZ

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Inquis Medical

FDA DECISIONS ON FILE

COVERAGE