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Chord-X ePTFE Suture

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121173

by On-Xlifetechnologies

Identifiers

510(k) Number
K121173 FDA 510(k)
FDA Product Code
PAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3470 FDA 510(k)
Regulation Number
870.3470 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Chord-X ePTFE Suture is a Nonabsorbable Expanded Polytetrafluoroethylene (ePTFE) Surgical Suture designed specifically for chordae tendineae repair or replacement. This monofilament suture is engineered to provide durable reinforcement in mitral valve restoration procedures, ensuring structural integrity where natural or damaged chordae require stabilization. Its ePTFE composition offers resistance to degradation and friction, making it suitable for high-stress cardiac applications. The device is classified under product code PAW and falls under FDA Class II regulatory oversight with special controls for cardiovascular applications.

The Chord-X ePTFE Suture is supplied in sterile, single-use packaging, with each box containing 12 pre-packaged sutures without pledgets. It is intended for use in elective cardiac surgical settings, where precise chordal repair or replacement is required. The suture is non-reusable and must be handled under sterile conditions to maintain integrity. Regulatory clearance (FDA 510(k) K121173) confirms its compliance with Abbreviated review standards under the Cardiovascular advisory committee. Storage and handling must adhere to manufacturer guidelines to preserve sterility and performance.

Frequently asked questions

What is the Chord-X ePTFE Suture used for?

The Chord-X ePTFE Suture is designed specifically for chordae tendineae repair or replacement during mitral valve restoration procedures. Its monofilament ePTFE composition provides durable reinforcement where natural or damaged chordae require stabilization, ensuring long-term structural integrity in high-stress cardiac applications.

How is the Chord-X ePTFE Suture supplied and packaged?

The suture is supplied in sterile, single-use packaging. Each box contains 12 pre-packaged sutures without pledgets, ensuring sterility and readiness for use in elective cardiac surgical settings.

Is the Chord-X ePTFE Suture reusable or single-use?

The Chord-X ePTFE Suture is intended for single-use only. It must be handled under sterile conditions to maintain its integrity and performance, as reuse could compromise sterility and structural reliability.

What regulatory clearance does the Chord-X ePTFE Suture have?

The Chord-X ePTFE Suture holds FDA 510(k) clearance (K121173) under the Cardiovascular advisory committee, confirming compliance with Abbreviated review standards for cardiovascular applications. It is classified under product code PAW and falls under FDA Class II regulatory oversight.

How should the Chord-X ePTFE Suture be stored?

The suture must be stored according to manufacturer guidelines to preserve sterility and performance. Proper storage conditions ensure the ePTFE material retains its resistance to degradation and friction, which is critical for its intended use in high-stress cardiac procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K121173 FDA 510(k) - CHORD-X EPTFE SUTURE | On-Xlifetechnologies, On-X CHORD-X ePTFE SUTURE Instructions For Use Manual, Mitral valve cardiac restoration system - Chord-X® - On-X Life Technologies, On-X Chord-X Series Instructions For Use Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
On-Xlifetechnologies

Sources (1)

  • FDA 510(k) K121173 24 fields · synced Oct 1, 2026