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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 / K260839

510(k) cleared

Protaryx Transseptal Puncture Device (PTX2-001)

Protaryx Medical, Inc. · Apr 10, 2026 · K260839

FDA cleared the Protaryx Transseptal Puncture Device (PTX2-001) from Protaryx Medical, Inc. on Apr 10, 2026 under K260839, a traditional 510(k) reviewed through the Third Party Review Program. 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 Mar 13, 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 Protaryx Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260839?

K260839 is the FDA 510(k) for Protaryx Transseptal Puncture Device (PTX2-001), submitted by Protaryx Medical, Inc.. FDA's decision date was Apr 10, 2026, under product code DYB (Introducer, Catheter).

Who makes the Protaryx Transseptal Puncture Device (PTX2-001)?

Protaryx Medical, Inc., based in Baltimore, MD, is the applicant of record for K260839.

How long did the K260839 review take?

FDA received the submission on Mar 13, 2026 and issued its decision on Apr 10, 2026, 28 days later.

← All decisions in April 2026