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510(k) Data Aggregation
K Number
K121173Device Name
CHORD-X EPTFE SUTURE
Manufacturer
ON-XLIFETECHNOLOGIES
Date Cleared
2012-08-16
(121 days)
Product Code
PAW
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
ON-XLIFETECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Chord-X ePTFE Suture for chordae tendinae repair or replacement is indicated for the repair or replacement of chordae tendinae.
Device Description
The device is a non-absorbable monofilament ePTFE suture provided in the following configurations and meeting the USP standards:
USP 2-0 with 3/8 circle needle (Model - CX2038A)
USP 2-0 with ½ circle needle (Model CX2012A)
USP 3-0 with 3/8 circle needle (Model - CX3038A)
USP 3-0 with ½ circle needle (Model CX3012A)
It is provided as a sterile, single use product and contains no dyes or additives.
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