Device Classification Name |
patch, pledget and intracardiac, petp, ptfe, polypropylene
|
510(k) Number |
K101740 |
Device Name |
ALBOSURE POLYESTER VASCULAR PATCH |
Applicant |
LEMAITRE VASCULAR, INC. |
63 2ND AVENUE |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
VIC ZHANG |
Correspondent |
LEMAITRE VASCULAR, INC. |
63 2ND AVENUE |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
VIC ZHANG |
Regulation Number | 870.3470
|
Classification Product Code |
|
Date Received | 06/21/2010 |
Decision Date | 09/20/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|