Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K143036 |
Device Name |
Ebony PTA 0.035 Peripheral Dilatation Catheter |
Applicant |
Natec Medical Ltd |
Maeva Centre Building Ebene Business Park |
Reduit,
MU
72201
|
|
Applicant Contact |
Xavier De Buchere |
Correspondent |
CardioMed Device Consultants, LLC |
5523 Research Park Drive |
Suite 205 |
Baltimore,
MD
21228
|
|
Correspondent Contact |
Judith Danielson |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 10/22/2014 |
Decision Date | 03/30/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|