510(k) Report

Devices descending from K953289

2 later devices reach Tetrafluoroethylene (Tfe) Polymer Pledget through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141060Chord-X Pre-Measured Loops for Mitral Chordal ReplacementOn-X Life Technologies, Inc.201411
+2K252126MitraPatch Mitral Valve Repair SystemChawla Heart Technologies, LLC20250—