Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K212977 |
Device Name |
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands |
Applicant |
Cordis Corporation |
14201 N.W. 60th Avenue |
Miami Lakes,
FL
33014
|
|
Applicant Contact |
Vidya Venkataraghavan |
Correspondent |
Cordis Corporation |
14201 N.W. 60th Avenue |
Miami Lakes,
FL
33014
|
|
Correspondent Contact |
Vidya Venkataraghavan |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 09/17/2021 |
Decision Date | 02/17/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|