Device Classification Name |
introducer, catheter
|
510(k) Number |
K130559 |
Device Name |
MOBICATH BI-DIRECTIONAL GUIDING SHEATH |
Applicant |
Greatbatch Medical |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
DENISE THOMPSON |
Correspondent |
Greatbatch Medical |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
DENISE THOMPSON |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/04/2013 |
Decision Date | 05/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|