Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K153125 |
Device Name |
IntraNovo Microcatheter |
Applicant |
Texas Medical Technologies, Inc. |
9005 Montana Ave., Suite A |
El Paso,
TX
79925
|
|
Applicant Contact |
Aaron Chiu |
Correspondent |
Smith Associates |
1468 Harwell Avenue |
Crofton,
MD
21114
|
|
Correspondent Contact |
EJ Smith |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 10/29/2015 |
Decision Date | 01/13/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|