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FDA 510(k)

MitraPatch Mitral Valve Repair System

K-Number: K252126 · 2025-12-04

ApplicantChawla Heart Technologies, LLC
Decision Date2025-12-04
Product CodePAW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MitraPatch Mitral Valve Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Chawla Heart Technologies, LLC. It received FDA 510(k) clearance on 2025-12-04 under 510(k) number K252126. The device is classified under product code PAW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MitraPatch Mitral Valve Repair System?

MitraPatch Mitral Valve Repair System is a medical device that received FDA 510(k) clearance on 2025-12-04. The listed applicant is Chawla Heart Technologies, LLC. The 510(k) number is K252126.

When did MitraPatch Mitral Valve Repair System receive FDA 510(k) clearance?

MitraPatch Mitral Valve Repair System received FDA 510(k) clearance on 2025-12-04, under 510(k) number K252126.

Who is the listed applicant for MitraPatch Mitral Valve Repair System?

The FDA 510(k) record lists Chawla Heart Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MitraPatch Mitral Valve Repair System?

The FDA product code for MitraPatch Mitral Valve Repair System is PAW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02245763STS/ACC TVT Registry Mitral ModuleRECRUITINGNCT02803957Randomized Trial of the Neochord DS1000 System Versus Open Surgical RepairACTIVE_NOT_RECRUITINGNCT03433274Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT04198870MitraClip REPAIR MR StudyACTIVE_NOT_RECRUITINGNCT04375332Beating Heart Mitral Valve Repair With the HARPOON™ SystemACTIVE_NOT_RECRUITING

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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