Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K122084 |
Device Name |
INTRODUCER SET, MODEL ADELANTE-S SERIES |
Applicant |
Oscor Inc. |
3816 DE SOTO BLVD. |
PALM HARBOR,
FL
34683
|
|
Applicant Contact |
MILA DOSKOCIL |
Correspondent |
Oscor Inc. |
3816 DE SOTO BLVD. |
PALM HARBOR,
FL
34683
|
|
Correspondent Contact |
MILA DOSKOCIL |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 07/16/2012 |
Decision Date | 08/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|