CHORD-X EPTFE SUTURE


Device Classification Name

nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement

510(k) Number K121173
Device Name CHORD-X EPTFE SUTURE
Applicant
ON-XLIFETECHNOLOGIES
1300 east anderson lane
bldg b
austin, 
TX 
78752

Applicant Contact john ely
Correspondent
ON-XLIFETECHNOLOGIES
1300 east anderson lane
bldg b
austin, 
TX 
78752

Correspodent Contact john ely
Regulation Number 878.5035
Classification Product Code
PAW  
Date Received 04/17/2012
Decision Date 08/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No