Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K110051 |
Device Name |
RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT |
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 | 870.1340
|
Classification Product Code |
|
Date Received | 01/07/2011 |
Decision Date | 02/02/2012 |
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
|
|
|