Cleared Special

K141060 - CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT (FDA 510(k) Clearance)

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

K141060 · On-X Life Technologies, Inc. · Cardiovascular device
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Jun 2014
Decision
43d
Days
Class 2
Risk

K141060 is an FDA 510(k) clearance for the CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT. Classified as Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement (product code PAW), Class II - Special Controls.

Submitted by On-X Life Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on June 6, 2014 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all On-X Life Technologies, Inc. devices

Submission Details

510(k) Number K141060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2014
Decision Date June 06, 2014
Days to Decision 43 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

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.