Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K232574 |
Device Name |
VASSALLO GT Crossing14 |
Applicant |
Filmec Co. Ltd. |
1703 Wakita-cho, Moriyama-ku |
Hagoya-shi,
JP
463-0024
|
|
Applicant Contact |
Toshiya Osawa |
Correspondent |
CordioMed Device Consultants |
1783 Forest Drive Suite 254 |
Annapolis,
MD
21401
|
|
Correspondent Contact |
Meagan Fagan |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 08/25/2023 |
Decision Date | 10/11/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|