The following data is part of a premarket notification filed by Suzhou Hengrui Hongyuan Medical Co., Ltd. with the FDA for Hrspheres Narrow-size Embolic Microspheres.
| Device ID | K210562 |
| 510k Number | K210562 |
| Device Name: | HRSpheres Narrow-Size Embolic Microspheres |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Suzhou Hengrui Hongyuan Medical Co., Ltd. Building B9 Unit 201, No. 218 Xinghu Road, SIP, Suzhou, CN 215123 |
| Contact | Qianqian Zhang |
| Correspondent | Qianqian Zhang Suzhou Hengrui Hongyuan Medical Co., Ltd. Building B9 Unit 201, No. 218 Xinghu Road, SIP, Suzhou, CN 215123 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2021-10-01 |