Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K120459 |
Device Name |
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO |
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 | 02/15/2012 |
Decision Date | 06/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|