Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K192599 |
Device Name |
ASAHI PTCA Guide Wire ASAHI Gaia Next |
Applicant |
Asahi Intecc Co., Ltd. |
3-100 Akatsuki-cho |
Seto,
JP
489-0071
|
|
Applicant Contact |
Yasuyuki Kawahara |
Correspondent |
Asahi Intecc USA, Inc. |
3002 Dow Ave, Suite 212 |
Tustin,
CA
92780
|
|
Correspondent Contact |
Cynthia Valenzuela |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 09/20/2019 |
Decision Date | 01/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|