Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K192782 |
Device Name |
ASAHI CROSSWALK Peripheral Support Catheter |
Applicant |
Asahi Intecc Co., Ltd. |
3-100 Akatsuki-cho |
seto,
JP
489-0071
|
|
Applicant Contact |
yasuyuki kawuhara |
Correspondent |
Asahi Intecc USA, Inc. |
3002 Dow Avenue, Suite 212 |
tustin,
CA
92780
|
|
Correspondent Contact |
cynthia valenzuela |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 09/30/2019 |
Decision Date | 11/29/2019 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|