Cleared Special

K141060 - CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT

K141060 is an FDA 510(k) clearance for CHORD-X PRE-MEASURED LOOPS FOR MITRAL C..., manufactured by On-X Life Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code PAW cleared through the Special 510(k) pathway after a 43-day FDA review.

K141060 · On-X Life Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K141060

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

PAW Device Classification - Class 2, Special Controls

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.

K141060 · CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT
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