Device Classification Name |
introducer, catheter
|
510(k) Number |
K202167 |
Device Name |
Brite Tip Radianz Guiding Sheath |
Applicant |
Cordis Corporation |
14201 NW 60th Avenue |
Miami Lakes,
FL
33014
|
|
Applicant Contact |
Crystal Placona |
Correspondent |
Cordis Corporation |
14201 NW 60th Avenue |
Miami Lakes,
FL
33014
|
|
Correspondent Contact |
Crystal Placona |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 08/03/2020 |
Decision Date | 02/26/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|