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Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

FDA product code PAW · Class 2 · Cardiovascular

40
Registered devices
10
Adverse events
1
Recalls
3
510(k) clearances

Devices with this code

Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.Chord-X Premeasured Loops and Suture System — ON-X LIFE TECHNOLOGIES, INC.

Recent recalls

DateFirmReason
2016-12-13On-X Life Technologies, Inc.Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plasti

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