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

Name: FDA 510(k) clearance K141060
Creator: U.S. Food and Drug Administration
Published: 2014-06-06

Substantially Equivalent

On-X Life Technologies, Inc.

FDA 510(k) clearance K141060 for CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT, Substantially Equivalent on 2014-06-06. Applicant: On-X Life Technologies, Inc.. Device class: 2.

Clearance details

Applicant: On-X Life Technologies, Inc.
Product code: Code PAW
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2014-04-24
Decision date: 2014-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K141060

K-number listed on FDA's recall record

Z-1057-2017 — Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.Class II·Terminated·On-X Life Technologies, Inc.·20161213

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141060.

Data sourced from openFDA. This site is unofficial and independent of the FDA.