Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K081846 |
Device Name |
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 |
Applicant |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Applicant Contact |
CHARMAINE SUTTON |
Correspondent |
VASCULAR SOLUTIONS, INC. |
6464 SYCAMORE COURT |
MINNEAPOLIS,
MN
55369
|
|
Correspondent Contact |
CHARMAINE SUTTON |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 06/30/2008 |
Decision Date | 01/28/2009 |
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
|
|
|