Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K191464 |
Device Name |
Asahi PTCA Guide Wire Asahi SION Series |
Applicant |
Asahi Intecc Co., LTD. |
3-100Akatsuki-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 | 06/03/2019 |
Decision Date | 11/21/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|