Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K121954 |
Device Name |
NMI MICROCATHETER |
Applicant |
NAVILYST MEDICAL, INC. |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
WANDA CARPINELLA |
Correspondent |
NAVILYST MEDICAL, INC. |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
WANDA CARPINELLA |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 07/03/2012 |
Decision Date | 07/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|