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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 / December 2025 / K252126

510(k) cleared

MitraPatch Mitral Valve Repair System

Chawla Heart Technologies, LLC · Dec 4, 2025 · K252126

FDA cleared the MitraPatch Mitral Valve Repair System from Chawla Heart Technologies, LLC on Dec 4, 2025 under K252126, a traditional 510(k). The device falls under product code PAW, Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement, regulated at 21 CFR 870.3470 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 7, 2025. The decision came 150 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Chawla Heart Technologies, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252126?

K252126 is the FDA 510(k) for MitraPatch Mitral Valve Repair System, submitted by Chawla Heart Technologies, LLC. FDA's decision date was Dec 4, 2025, under product code PAW (Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement).

Who makes the MitraPatch Mitral Valve Repair System?

Chawla Heart Technologies, LLC, based in Bloomfield, CT, is the applicant of record for K252126.

How long did the K252126 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Dec 4, 2025, 150 days later.

← All decisions in December 2025