Device Classification Name |
balloon aortic valvuloplasty
|
510(k) Number |
K220881 |
Device Name |
INOUE BALLOON A |
Applicant |
Toray Industries, Inc. |
1-1, Nihombashi-Muromachi 2-Chome |
Chuo-ku,
JP
103-8666
|
|
Applicant Contact |
Satoshi Kakuyama |
Correspondent |
Toray Industries (America), Inc. |
461 Fifth Avenue, 9th Floor |
New York,
NY
10017
|
|
Correspondent Contact |
Yuya Shizume |
Regulation Number | 870.1255
|
Classification Product Code |
|
Date Received | 03/25/2022 |
Decision Date | 12/18/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|