Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K093232 |
Device Name |
OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER |
Applicant |
Greatbatch Medical |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Applicant Contact |
SHANNON SPRINGER |
Correspondent |
Greatbatch Medical |
2300 BERKSHIRE LANE NORTH |
MINNEAPOLIS,
MN
55441
|
|
Correspondent Contact |
SHANNON SPRINGER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 10/14/2009 |
Decision Date | 03/15/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|