FDA 510(k), K121173, CHORD-X EPTFE SUTURE

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

• Total Pages: 930
• Fully Redacted Pages: 17
• Content Pages: 913 (total pages minus fully redacted pages)