Device Classification Name |
Aspiration Thrombectomy Catheter
|
510(k) Number |
K112571 |
Device Name |
XL EXTRACTION 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 | 870.5150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/06/2011 |
Decision Date | 10/06/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|