Cleared Abbreviated

CHORD-X EPTFE SUTURE (K121173) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K121173 · On-Xlifetechnologies · Cardiovascular device
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Aug 2012
Decision
121d
Days
Class 2
Risk

K121173 is an FDA 510(k) clearance for the CHORD-X EPTFE SUTURE. Classified as Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement (product code PAW), Class II - Special Controls.

Submitted by On-Xlifetechnologies (Austin, US). The FDA issued a Cleared decision on August 16, 2012 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

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Submission Details

510(k) Number K121173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2012
Decision Date August 16, 2012
Days to Decision 121 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
Definition To Repair Or Replace Chordae Tendinae.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.