Device Classification Name |
catheter, steerable
|
510(k) Number |
K112541 |
Device Name |
Z FLEX-270TM STEERABLE SHEATH |
Applicant |
Greatbatch Medical |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
SARA BAKKER |
Correspondent |
Greatbatch Medical |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
SARA BAKKER |
Regulation Number | 870.1280
|
Classification Product Code |
|
Date Received | 09/01/2011 |
Decision Date | 02/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|