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FDA 510(k), K121173, CHORD-X EPTFE SUTURE
FDA 510(k), K121173, CHORD-X EPTFE SUTURE
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510(K) Number: K121173
Device Name: CHORD-X EPTFE SUTURE
Manufacturer: ON-XLIFETECHNOLOGIES
Device Classification Name: nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement
Regulation Number: 870.3470
Classification Product Code: PAW
Date Received: 04/17/2012
Decision Date: 08/16/2012
Regulation Medical Specialty: Cardiovascular
Device Name: CHORD-X EPTFE SUTURE
Manufacturer: ON-XLIFETECHNOLOGIES
Device Classification Name: nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement
Regulation Number: 870.3470
Classification Product Code: PAW
Date Received: 04/17/2012
Decision Date: 08/16/2012
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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