Device Classification Name |
nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replacement
|
510(k) Number |
K141060 |
Device Name |
CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT |
Applicant |
ON-X LIFE TECHNOLOGIES, INC. |
1300 East anderson Lane |
Building B |
Austin,
TX
78752
|
|
Applicant Contact |
JOHN ELY |
Correspondent |
ON-X LIFE TECHNOLOGIES, INC. |
1300 East anderson Lane |
Building B |
Austin,
TX
78752
|
|
Correspondent Contact |
JOHN ELY |
Regulation Number | 870.3470
|
Classification Product Code |
|
Date Received | 04/24/2014 |
Decision Date | 06/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|