Device Classification Name |
Catheter, Intravascular Occluding, Temporary
|
510(k) Number |
K122576 |
Device Name |
TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT |
Applicant |
STRYKER NEUROVASCULAR |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538
|
|
Applicant Contact |
JAMES LEATHLEY |
Correspondent |
STRYKER NEUROVASCULAR |
47900 BAYSIDE PARKWAY |
FREMONT,
CA
94538
|
|
Correspondent Contact |
JAMES LEATHLEY |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 08/23/2012 |
Decision Date | 01/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|