Device Classification Name |
Aspiration Thrombectomy Catheter
|
510(k) Number |
K120808 |
Device Name |
EXPORT XT CATHETER, EXPORT AP CATHETER |
Applicant |
MEDTRONIC INC. |
35-37A CHERRY HILL DRIVE |
DANVERS,
MA
01923 -5186
|
|
Applicant Contact |
ANU GAUR |
Correspondent |
MEDTRONIC INC. |
35-37A CHERRY HILL DRIVE |
DANVERS,
MA
01923 -5186
|
|
Correspondent Contact |
ANU GAUR |
Regulation Number | 870.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/16/2012 |
Decision Date | 06/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|