Device Classification Name |
Aspiration Thrombectomy Catheter
|
510(k) Number |
K061958 |
Device Name |
MEDTRONIC EXPORT XT CATHETER |
Applicant |
MEDTRONIC VASCULAR |
37A CHERRY HILL DR. |
DANVERS,
MA
01923
|
|
Applicant Contact |
KAREN A BROZOWSKI |
Correspondent |
MEDTRONIC VASCULAR |
37A CHERRY HILL DR. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
KAREN A BROZOWSKI |
Regulation Number | 870.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/11/2006 |
Decision Date | 09/05/2006 |
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
|