DeviceClearance

Product code PAW— Cardiovascular

CHORD-X EPTFE SUTURE

Classification name
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Device class
Class 2
Regulation
21 CFR 870.3470
Advisory panel
Cardiovascular
Total cleared
3
First cleared
Most recent

FDA classification definition

“To repair or replace chordae tendinae.”

— U.S. Food and Drug Administration, device classification record for product code PAW under 21 CFR 870.3470, via openFDA

Market context for product code PAW

FDA has cleared 3 devices under product code PAW between 2012 and 2025, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PAW

Recent clearances under product code PAW

Data sourced from openFDA. This site is unofficial and independent of the FDA.