Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K141206 |
Device Name |
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM |
Applicant |
EDWARDS LIFESCIENCES LLC. |
12050 Lone Peak Pkwy |
Draper,
UT
84020
|
|
Applicant Contact |
Nina Brooke |
Correspondent |
EDWARDS LIFESCIENCES LLC. |
12050 Lone Peak Pkwy |
Draper,
UT
84020
|
|
Correspondent Contact |
Nina Brooke |
Regulation Number | 878.5010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/09/2014 |
Decision Date | 01/16/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|