510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141060Substantially Equivalent

Chord-X Pre-Measured Loops for Mitral Chordal Replacement

On-X Life Technologies Inc., Austin TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141060 is the FDA 510(k) clearance record for CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT, a class II device, cleared for On-X Life Technologies, Inc. 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-X Life Technologies, Inc. As of , FDA records show one recall naming K141060.

Clearance record

Decision date
Received
(43 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-X Life Technologies, Inc. 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