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 / February 2026 / K260163

510(k) cleared

AuST CSP Introducer

CenterPoint Systems, LLC · Feb 19, 2026 · K260163

FDA cleared the AuST CSP Introducer from CenterPoint Systems, LLC on Feb 19, 2026 under K260163, a special 510(k). 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 Jan 20, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

CenterPoint Systems, LLC has 4 other decisions in the tracker over the last 12 months: K261766 (CPS Locator 3D Plus Delivery Catheter), K262240 (SSPC NXT Delivery Catheter), K261492 (FieldFlex Steerable Sheath), K260942 (AuST Steerable Sheath).

Questions & Answers

What did FDA clear under K260163?

K260163 is the FDA 510(k) for AuST CSP Introducer, submitted by CenterPoint Systems, LLC. FDA's decision date was Feb 19, 2026, under product code DYB (Introducer, Catheter).

Who makes the AuST CSP Introducer?

CenterPoint Systems, LLC, based in West Valley City, UT, is the applicant of record for K260163.

How long did the K260163 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Feb 19, 2026, 30 days later.

← All decisions in February 2026

Sources