Device Classification Name |
valvulotome
|
510(k) Number |
K190267 |
Device Name |
EZE SIT Valvulotome |
Applicant |
LeMaitre Vascular |
63 Second Avenue |
Burlington,
MA
01803
|
|
Applicant Contact |
John N. Bradsher |
Correspondent |
LeMaitre Vascular |
63 Second Avenue |
Burlington,
MA
01803
|
|
Correspondent Contact |
John N. Bradsher |
Regulation Number | 870.4885
|
Classification Product Code |
|
Date Received | 02/08/2019 |
Decision Date | 10/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|