Device Classification Name |
introducer, catheter
|
510(k) Number |
K102540 |
Device Name |
PTFE PORTABLE INTRODUCER |
Applicant |
Greatbatch Medical |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
Kristi Fox |
Correspondent |
Greatbatch Medical |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
Kristi Fox |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/03/2010 |
Decision Date | 11/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|