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 / January 2026 / P250009

PMA approved

SQUID Liquid Embolic Agent (LEA)

Balt USA, LLC · Jan 30, 2026 · P250009

FDA approved the SQUID Liquid Embolic Agent (LEA) from Balt USA, LLC on Jan 30, 2026 under P250009, an original premarket approval. The device falls under product code SGU, Neurovascular Liquid Embolic Agent as a Class 3 device. The review panel was Neurology.

FDA logged the submission as received on Mar 21, 2025. The decision came 315 days later.

Balt USA, LLC has 5 other decisions in the tracker over the last 12 months: K260199 (SLIM Microcatheter), K254223 (Next Generation 088 Catheter), K254221 (Optima Coil System (OptiOne Coil System)), K252569 (Carrier XL Delivery Catheter).

Questions & Answers

What did FDA approve under P250009?

P250009 is the FDA PMA for SQUID Liquid Embolic Agent (LEA), submitted by Balt USA, LLC. FDA's decision date was Jan 30, 2026, under product code SGU (Neurovascular Liquid Embolic Agent).

Who makes the SQUID Liquid Embolic Agent (LEA)?

Balt USA, LLC, based in Irvine, CA, is the applicant of record for P250009.

How long did the P250009 review take?

FDA received the submission on Mar 21, 2025 and issued its decision on Jan 30, 2026, 315 days later.

← All decisions in January 2026