Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K192267 |
Device Name |
ILUMIEN System with AptiVue Software version D.3 |
Applicant |
Abbott Medical |
4 Robbins Road |
Westford,
MA
01886
|
|
Applicant Contact |
Anita Xavier |
Correspondent |
Abbott Medical |
4 Robbins Road |
Westford,
MA
01886
|
|
Correspondent Contact |
Anita Xavier |
Regulation Number | 870.1200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/21/2019 |
Decision Date | 12/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|