Cleared Traditional

K252126 - MitraPatch Mitral Valve Repair System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252126 · Chawla Heart Technologies, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
150d
Days
Class 2
Risk

K252126 is an FDA 510(k) clearance for the MitraPatch Mitral Valve Repair System. Classified as Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement (product code PAW), Class II - Special Controls.

Submitted by Chawla Heart Technologies, LLC (Bloomfield, US). The FDA issued a Cleared decision on December 4, 2025 after a review of 150 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Chawla Heart Technologies, LLC devices

Submission Details

510(k) Number K252126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2025
Decision Date December 04, 2025
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
Definition To Repair Or Replace Chordae Tendinae.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

CardioMed Device Consultants, LLC
Semih Oktay

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.