Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K121763 |
Device Name |
MULTICROSS SUPPORT CATHETER |
Applicant |
ROXWOOD MEDICAL, INC. |
150 EXECUTIVE PARK BLVD, STE 3700 |
SAN FRANCISCO,
CA
94134
|
|
Applicant Contact |
MEHRDAD FARHANGNIA |
Correspondent |
ROXWOOD MEDICAL, INC. |
150 EXECUTIVE PARK BLVD, STE 3700 |
SAN FRANCISCO,
CA
94134
|
|
Correspondent Contact |
MEHRDAD FARHANGNIA |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 06/15/2012 |
Decision Date | 11/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|