Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K081878 |
Device Name |
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM |
Applicant |
LEMAITRE VASCULAR, INC. |
63 SECOND AVENUE |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
ERIN DALY |
Correspondent |
LEMAITRE VASCULAR, INC. |
63 SECOND AVENUE |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
ERIN DALY |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/02/2008 |
Decision Date | 01/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|