Device Classification Name |
Catheter, Steerable
|
510(k) Number |
K120086 |
Device Name |
CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM |
Applicant |
CARDIOSOLUTIONS |
375 WEST ST. |
WEST BRIDGEWATER,
MA
02379
|
|
Applicant Contact |
MICHELE LUCEY |
Correspondent |
CARDIOSOLUTIONS |
375 WEST ST. |
WEST BRIDGEWATER,
MA
02379
|
|
Correspondent Contact |
MICHELE LUCEY |
Regulation Number | 870.1280
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/11/2012 |
Decision Date | 04/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|