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 / July 2026 / K262240

510(k) cleared

SSPC NXT Delivery Catheter

CenterPoint Systems, LLC · Jul 29, 2026 · K262240

FDA cleared the SSPC NXT Delivery Catheter from CenterPoint Systems, LLC on Jul 29, 2026 under K262240, a special 510(k). The device falls under product code DQY, Catheter, Percutaneous, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 1, 2026. The decision came 28 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), K261492 (FieldFlex Steerable Sheath), K260942 (AuST Steerable Sheath), K260163 (AuST CSP Introducer).

Questions & Answers

What did FDA clear under K262240?

K262240 is the FDA 510(k) for SSPC NXT Delivery Catheter, submitted by CenterPoint Systems, LLC. FDA's decision date was Jul 29, 2026, under product code DQY (Catheter, Percutaneous).

Who makes the SSPC NXT Delivery Catheter?

CenterPoint Systems, LLC, based in West Valley City, UT, is the applicant of record for K262240.

How long did the K262240 review take?

FDA received the submission on Jul 1, 2026 and issued its decision on Jul 29, 2026, 28 days later.

← All decisions in July 2026

Sources