FDA Product Code PAW: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
To Repair Or Replace Chordae Tendinae.
Leading manufacturers include On-Xlifetechnologies, On-X Life Technologies, Inc. and Chawla Heart Technologies, LLC.
3
Total
3
Cleared
105d
Avg days
2012
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
150d
recently vs 82d historically
FDA 510(k) Cleared Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement Devices (Product Code PAW)
3 devices
Cleared
Dec 04, 2025
MitraPatch Mitral Valve Repair System
Chawla Heart Technologies, LLC
Cardiovascular
150d
Cleared
Jun 06, 2014
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
On-X Life Technologies, Inc.
Cardiovascular
43d
Cleared
Aug 16, 2012
CHORD-X EPTFE SUTURE
On-Xlifetechnologies
Cardiovascular
121d
About Product Code PAW - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PAW since 2012, with 3 receiving FDA clearance (average review time: 105 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PAW Product Code
Recent submissions under PAW have taken an average of 150 days to reach a decision - up from 82 days historically. Manufacturers should account for longer review timelines in current project planning.
PAW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →