Device Classification Name |
Dilator, Vessel, For Percutaneous Catheterization
|
510(k) Number |
K132713 |
Device Name |
NMI COAXIAL MICROINTRODUCER SET |
Applicant |
NAVILYST MEDICAL, INC. |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
MICHAEL P HANLEY |
Correspondent |
NAVILYST MEDICAL, INC. |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
MICHAEL P HANLEY |
Regulation Number | 870.1310
|
Classification Product Code |
|
Date Received | 08/30/2013 |
Decision Date | 09/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|