Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K112082 |
Device Name |
GUIDELINER V2 CATHETER |
Applicant |
VASCULAR SOLUTIONS, INC. |
6464 Sycamore Court North |
Minneapolis,
MN
55369
|
|
Applicant Contact |
MATT NIENSTEDT |
Correspondent |
VASCULAR SOLUTIONS, INC. |
6464 Sycamore Court North |
Minneapolis,
MN
55369
|
|
Correspondent Contact |
MATT NIENSTEDT |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/21/2011 |
Decision Date | 12/01/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|