Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K192783 |
Device Name |
Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile |
Applicant |
Scientia Vascular LLC |
3487 West 2100 South Suite 100 |
West Valley City,
UT
84119
|
|
Applicant Contact |
Amy McManus |
Correspondent |
Scientia Vascular LLC |
3487 West 2100 South Suite 100 |
West Valley City,
UT
84119
|
|
Correspondent Contact |
Amy McManus |
Regulation Number | 870.1330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/2019 |
Decision Date | 10/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|