Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K121839 |
Device Name |
UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
Applicant |
LEMAITRE VASCULAR INC. |
63 SECOND AVENUE |
BEDFORD,
MA
01803
|
|
Applicant Contact |
ANDREW HODGKINSON |
Correspondent |
LEMAITRE VASCULAR INC. |
63 SECOND AVENUE |
BEDFORD,
MA
01803
|
|
Correspondent Contact |
ANDREW HODGKINSON |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/22/2012 |
Decision Date | 08/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|