FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
HRSpheres Narrow-Size Embolic Microspheres
K Number: K210562
·
Decision Oct 1, 2021
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
2
Review Days
218
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Basic Information
- Device Name
- HRSpheres Narrow-Size Embolic Microspheres
- K Number
- K210562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suzhou Hengrui Hongyuan Medical Co., Ltd.
- Date Received
- February 25, 2021
- Decision Date
- October 1, 2021
- Product Code
- KRD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | FDA class 2 | Cardiovascular |
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Other Clearances by Suzhou Hengrui Hongyuan Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K212719 | Micro Catheter and Guidewire System | Apr 11, 2022 | Substantially Equivalent |