Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K152456 |
Device Name |
CenterCross Ultra Catheter |
Applicant |
ROXWOOD MEDICAL, INC. |
400 SEAPORT CT, |
SUITE #103 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
Grace Li |
Correspondent |
ROXWOOD MEDICAL, INC. |
400 SEAPORT CT, |
SUITE #103 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
Grace Li |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 08/28/2015 |
Decision Date | 01/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|