Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
510(k) Number K252126
Device Name MitraPatch Mitral Valve Repair System
Applicant
Chawla Heart Technologies, LLC
7 Seminole Way
Bloomfield,  CT  06002
Applicant Contact Surendra Chawla
Correspondent
CardioMed Device Consultants, LLC
3168 Braverton St. Suite 200
Edgewater,  MD  21037
Correspondent Contact Semih Oktay
Regulation Number870.3470
Classification Product Code
PAW  
Date Received07/07/2025
Decision Date 12/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-