Device Classification Name |
temporary coronary saphenous vein bypass graft for embolic protection
|
510(k) Number |
K073563 |
Device Name |
MODIFICATION TO PROXIS SYSTEM |
Applicant |
ST. JUDE MEDICAL |
6550 WEDGWOOD RD. NORTH |
SUITE 150 |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
LINH PHAM |
Correspondent |
ST. JUDE MEDICAL |
6550 WEDGWOOD RD. NORTH |
SUITE 150 |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
LINH PHAM |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 12/19/2007 |
Decision Date | 01/31/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|