Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K182420 |
Device Name |
ASAHI Corsair Pro XS |
Applicant |
Asahi Intecc Co., Ltd. |
3-100 Akatsuki-cho |
Seto,
JP
489-0071
|
|
Applicant Contact |
Yasuyuki Kawahara |
Correspondent |
Cardiomed Device Consultants, LLC |
3168 Braverton Street, Suite 200 |
Edgewater,
MD
21037
|
|
Correspondent Contact |
Candace Cederman |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/05/2018 |
Decision Date | 12/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|