WHERE ARE YOU?

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 Tracker / March 2026 / K260626

510(k) cleared

Multiflex Steerable Sheath 17.5F

Vizaramed, Inc. · Mar 26, 2026 · K260626

FDA cleared the Multiflex Steerable Sheath 17.5F from Vizaramed, Inc. on Mar 26, 2026 under K260626, a special 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 26, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260626?

K260626 is the FDA 510(k) for Multiflex Steerable Sheath 17.5F, submitted by Vizaramed, Inc.. FDA's decision date was Mar 26, 2026, under product code DYB (Introducer, Catheter).

Who makes the Multiflex Steerable Sheath 17.5F?

Vizaramed, Inc., based in San Jose, CA, is the applicant of record for K260626.

How long did the K260626 review take?

FDA received the submission on Feb 26, 2026 and issued its decision on Mar 26, 2026, 28 days later.

← All decisions in March 2026