Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K083422 |
Device Name |
6F TAIGA GUIDING CATHETER |
Applicant |
MEDTRONIC VASCULAR |
37A CHERRY HILL DRIVE |
DANVERS,
MA
01923
|
|
Applicant Contact |
VIC ZHANG |
Correspondent |
MEDTRONIC VASCULAR |
37A CHERRY HILL DRIVE |
DANVERS,
MA
01923
|
|
Correspondent Contact |
VIC ZHANG |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 11/19/2008 |
Decision Date | 02/06/2009 |
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
|
|
|