The following data is part of a premarket notification filed by Suzhou Hengrui Callisyn Biomedical Co., Ltd. with the FDA for Callispheres Embolic Microspheres, 8spheres Embolic Microspheres.
| Device ID | K173871 |
| 510k Number | K173871 |
| Device Name: | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres |
| Classification | Agents, Embolic, For Treatment Of Uterine Fibroids |
| Applicant | Suzhou Hengrui Callisyn Biomedical Co., Ltd. Buliding 9, No. 8 Jinfeng Road, New District Suzhou, CN 215163 |
| Contact | Xiao Chen |
| Correspondent | Xiao Chen Suzhou Hengrui Callisyn Biomedical Co., Ltd. Buliding 9, No. 8 Jinfeng Road, New District Suzhou, CN 215163 |
| Product Code | NAJ |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-20 |
| Decision Date | 2018-09-17 |
| Summary: | summary |