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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 / September 2025 / K252527

510(k) cleared

Surfacer Inside-Out Access Catheter System

Merit Medical System, Inc. · Sep 10, 2025 · K252527

FDA cleared the Surfacer Inside-Out Access Catheter System from Merit Medical System, Inc. on Sep 10, 2025 under K252527, a special 510(k). The device falls under product code QJH, Reverse Central Venous Recanalization System, regulated at 21 CFR 870.1342 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 11, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Merit Medical System, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252527?

K252527 is the FDA 510(k) for Surfacer Inside-Out Access Catheter System, submitted by Merit Medical System, Inc.. FDA's decision date was Sep 10, 2025, under product code QJH (Reverse Central Venous Recanalization System).

Who makes the Surfacer Inside-Out Access Catheter System?

Merit Medical System, Inc., based in South Jordan, UT, is the applicant of record for K252527.

How long did the K252527 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Sep 10, 2025, 30 days later.

← All decisions in September 2025