Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K202060 |
Device Name |
Disposable IV catheter |
Applicant |
Shinva Ande Healthcare Apparatus Co., Ltd. |
No.77 Development Zone North Road |
Zibo,
CN
255086
|
|
Applicant Contact |
Liang Wanjie |
Correspondent |
Beijing Believe-Med Technology Service Co.,Ltd |
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. |
FangShan District,
CN
102401
|
|
Correspondent Contact |
Ray Wang |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 07/27/2020 |
Decision Date | 07/23/2021 |
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
|
|
|