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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 / May 2026 / K253855

510(k) cleared

KardiaPSI Balloon Catheter

Intervention Tech, Inc. ; dba Corvention · May 6, 2026 · K253855

FDA cleared the KardiaPSI Balloon Catheter from Intervention Tech, Inc. ; dba Corvention on May 6, 2026 under K253855, a traditional 510(k). The device falls under product code OZT, Balloon Aortic Valvuloplasty, regulated at 21 CFR 870.1255 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 3, 2025. The decision came 154 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 Intervention Tech, Inc. ; dba Corvention in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253855?

K253855 is the FDA 510(k) for KardiaPSI Balloon Catheter, submitted by Intervention Tech, Inc. ; dba Corvention. FDA's decision date was May 6, 2026, under product code OZT (Balloon Aortic Valvuloplasty).

Who makes the KardiaPSI Balloon Catheter?

Intervention Tech, Inc. ; dba Corvention, based in Flagstaff, AZ, is the applicant of record for K253855.

How long did the K253855 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on May 6, 2026, 154 days later.

← All decisions in May 2026