Device Classification Name |
wire, guide, catheter
|
510(k) Number |
K222631 |
Device Name |
VASSALLO GT EXT |
Applicant |
Filmecc Co. Ltd. |
1703 Wakita-cho, Moriyama-ku |
Nagoya-shi,
JP
463-0024
|
|
Applicant Contact |
Toshiya Osawa |
Correspondent |
CardioMed Device Consultants, LLC |
1783 Forest Drive, Suite 254 |
Annapolis,
MD
21401
|
|
Correspondent Contact |
Candace Cederman |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 08/31/2022 |
Decision Date | 10/26/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|