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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 / September 2025 / K252315

510(k) cleared

Santreva-ATK Endovascular Revasculariztion Catheter

AngioSafe, Inc. · Sep 22, 2025 · K252315

FDA cleared the Santreva-ATK Endovascular Revasculariztion Catheter from AngioSafe, Inc. on Sep 22, 2025 under K252315, a traditional 510(k). The device falls under product code PDU, Catheter For Crossing Total Occlusions, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 25, 2025. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for AngioSafe, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252315?

K252315 is the FDA 510(k) for Santreva-ATK Endovascular Revasculariztion Catheter, submitted by AngioSafe, Inc.. FDA's decision date was Sep 22, 2025, under product code PDU (Catheter For Crossing Total Occlusions).

Who makes the Santreva-ATK Endovascular Revasculariztion Catheter?

AngioSafe, Inc., based in San Jose, CA, is the applicant of record for K252315.

How long did the K252315 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Sep 22, 2025, 59 days later.

← All decisions in September 2025