The following data is part of a premarket notification filed by Shinva Ande Healthcare Apparatus Co., Ltd. with the FDA for Disposable Iv Catheter.
| Device ID | K202060 |
| 510k Number | K202060 |
| Device Name: | Disposable IV Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Shinva Ande Healthcare Apparatus Co., Ltd. No.77 Development Zone North Road Zibo, CN 255086 |
| Contact | Liang Wanjie |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co.,Ltd Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. Fangshan District, CN 102401 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-27 |
| Decision Date | 2021-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 36941512151086 | K202060 | 000 |
| 36941512150881 | K202060 | 000 |
| 36941512150898 | K202060 | 000 |
| 36941512150904 | K202060 | 000 |
| 36941512150911 | K202060 | 000 |
| 36941512150928 | K202060 | 000 |
| 36941512150935 | K202060 | 000 |
| 36941512150942 | K202060 | 000 |
| 36941512151024 | K202060 | 000 |
| 36941512151031 | K202060 | 000 |
| 36941512151048 | K202060 | 000 |
| 36941512151055 | K202060 | 000 |
| 36941512151062 | K202060 | 000 |
| 36941512151079 | K202060 | 000 |
| 00850050764328 | K202060 | 000 |