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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 / July 2026 / K260199

510(k) cleared

SLIM Microcatheter

Balt USA, LLC · Jul 13, 2026 · K260199

FDA cleared the SLIM Microcatheter from Balt USA, LLC on Jul 13, 2026 under K260199, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 22, 2026. The decision came 172 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Balt USA, LLC has 5 other decisions in the tracker over the last 12 months: K254223 (Next Generation 088 Catheter), P250009 (SQUID Liquid Embolic Agent (LEA)), K254221 (Optima Coil System (OptiOne Coil System)), K252569 (Carrier XL Delivery Catheter).

Questions & Answers

What did FDA clear under K260199?

K260199 is the FDA 510(k) for SLIM Microcatheter, submitted by Balt USA, LLC. FDA's decision date was Jul 13, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the SLIM Microcatheter?

Balt USA, LLC, based in Irvine, CA, is the applicant of record for K260199.

How long did the K260199 review take?

FDA received the submission on Jan 22, 2026 and issued its decision on Jul 13, 2026, 172 days later.

← All decisions in July 2026

Sources