Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K151951 |
Device Name |
Destino Reach |
Applicant |
Oscor Inc. |
3816 DeSoto Blvd |
Palm Harbor,
FL
34683
|
|
Applicant Contact |
Jan Flegeau |
Correspondent |
Oscor Inc. |
3816 DeSoto Blvd |
Palm Harbor,
FL
34683
|
|
Correspondent Contact |
Jan Flegeau |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 07/15/2015 |
Decision Date | 09/22/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|