Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K080264 |
Device Name |
MODIFICATION TO: FOX PLUS PTA CATHETER |
Applicant |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
Ivalee Cohen |
Correspondent |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
Ivalee Cohen |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 02/01/2008 |
Decision Date | 03/26/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|