Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K032041 |
Device Name |
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) |
Applicant |
LEMAITRE VASCULAR, INC. |
63 2ND AVENUE |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
CARLOS CHAPARRO |
Correspondent |
LEMAITRE VASCULAR, INC. |
63 2ND AVENUE |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
CARLOS CHAPARRO |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 07/01/2003 |
Decision Date | 08/27/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|