# K141060: Chord-X Pre-Measured Loops for Mitral Chordal Replacement

- Pathway: 510(k) (Special)
- Applicant: On-X Life Technologies, Inc.
- Decided: Jun 6, 2014 after 43 days
- Product code: PAW (Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement)
- Device class: 2
- Regulation: 21 CFR 870.3470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953289 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953289: Tetrafluoroethylene (Tfe) Polymer Pledget, Davis & Geck, Inc. (1995) Summary page 5.

## Cited in the summary but kept off the family tree
- K021173: Chord-X ePTFE Suture. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K252126: MitraPatch Mitral Valve Repair System (2025), 0 descendants of its own

## Recalls of this device
- Dec 13, 2016 · Class II · Z-1057-2017: Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed pr

## Indications for use
Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated for the repair or replacement of chordae tendinae.

Source page: https://510kreport.com/device/K141060
Methodology: https://510kreport.com/methodology