PAW

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

Product code
PAW
Device name
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Device class
Class 2
21 CFR
21 CFR 870.3470
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Implant
Flag
Life-sustaining / life-supporting
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

FDA classification definition

To repair or replace chordae tendinae.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-12-04.

NumberDecision dateApplicantDevice nameSummary
K2521262025-12-04Chawla Heart Technologies, LLCMitraPatch Mitral Valve Repair SystemPDF

1 summaries are archived here for direct download.

Official FDA classification page: PAW
Classification and pathway per current FDA publications. Data from openFDA (CC0).