The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Rotatable Snares, Non-rotatable Snares.
| Device ID | K172758 |
| 510k Number | K172758 |
| Device Name: | Rotatable Snares, Non-Rotatable Snares |
| Classification | Snare, Flexible |
| Applicant | Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou, CN 311100 |
| Contact | Lucius Long |
| Correspondent | Lucius Long Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou, CN 311100 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-13 |
| Decision Date | 2018-03-07 |
| Summary: | summary |