Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K094062 |
Device Name |
PERCU-PRO GUIDEWIRE |
Applicant |
CARDIOSOLUTIONS INC |
75 MILL STREET |
STOUGHTON,
MA
02072
|
|
Applicant Contact |
MICHELE LUCEY |
Correspondent |
CARDIOSOLUTIONS INC |
75 MILL STREET |
STOUGHTON,
MA
02072
|
|
Correspondent Contact |
MICHELE LUCEY |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 12/31/2009 |
Decision Date | 09/27/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|