510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121173Substantially Equivalent

Chord-X Eptfe Suture

On-Xlifetechnologies, Austin TX / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121173 is the FDA 510(k) clearance record for CHORD-X EPTFE SUTURE, a class II device, cleared for On-Xlifetechnologies on under FDA product code PAW (Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement). FDA's definition for product code PAW reads: "To repair or replace chordae tendinae". FDA records list one 510(k) clearance for On-Xlifetechnologies. As of , FDA records show no recalls naming K121173.

Clearance record

Decision date
Received
(121 days to decision)
Product code
PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Applicant
On-Xlifetechnologies 1300 E. Anderson Ln., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PAW

Trailing 12 months
1 clearance under product code PAW in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PAW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260