Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K122468 |
Device Name |
ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO |
Applicant |
ASAHI INTECC CO., LTD. |
2500 RED HILL SUITE 210 |
SANTA ANA,,
CA
92705
|
|
Applicant Contact |
YOSHI TERAI |
Correspondent |
ASAHI INTECC CO., LTD. |
2500 RED HILL SUITE 210 |
SANTA ANA,,
CA
92705
|
|
Correspondent Contact |
YOSHI TERAI |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 08/13/2012 |
Decision Date | 03/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|