Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K181237 |
Device Name |
Glidesheath Slender Tibial Pedal Kit |
Applicant |
Terumo Medical Corporation |
950 Elkton Blvd. |
Elkton,
MD
21921
|
|
Applicant Contact |
Liang Lu |
Correspondent |
Terumo Medical Corporation |
950 Elkton Blvd. |
Elkton,
MD
21921
|
|
Correspondent Contact |
Liang Lu |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 05/10/2018 |
Decision Date | 08/03/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02786173
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|