Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K172496 |
Device Name |
SUPERCATH 5 (26G) |
Applicant |
TOGO Medikit Co., Ltd. |
17148-6 Aza Kamekawa |
Oaza Hichiya |
Hyuga City,
JP
883-0062
|
|
Applicant Contact |
Daisuke Nagamizu |
Correspondent |
TOGO Medikit Co., Ltd. |
17148-6 Aza Kamekawa |
Oaza Hichiya |
Hyuga City,
JP
883-0062
|
|
Correspondent Contact |
Daisuke Nagamizu |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 08/18/2017 |
Decision Date | 03/23/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|