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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 / October 2025 / K252569

510(k) cleared

Carrier XL Delivery Catheter

Balt USA, LLC · Oct 22, 2025 · K252569

FDA cleared the Carrier XL Delivery Catheter from Balt USA, LLC on Oct 22, 2025 under K252569, a special 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 Aug 14, 2025. The decision came 69 days later, inside the 90 FDA-day goal for a 510(k).

Balt USA, LLC has 5 other decisions in the tracker over the last 12 months: K260199 (SLIM Microcatheter), K254223 (Next Generation 088 Catheter), P250009 (SQUID Liquid Embolic Agent (LEA)), K254221 (Optima Coil System (OptiOne Coil System)).

Questions & Answers

What did FDA clear under K252569?

K252569 is the FDA 510(k) for Carrier XL Delivery Catheter, submitted by Balt USA, LLC. FDA's decision date was Oct 22, 2025, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Carrier XL Delivery Catheter?

Balt USA, LLC, based in Irvine, CA, is the applicant of record for K252569.

How long did the K252569 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Oct 22, 2025, 69 days later.

← All decisions in October 2025

Sources