FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
K Number: K173871
·
Decision Sep 17, 2018
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
7
Applicant Total
1
Review Days
271
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Basic Information
- Device Name
- CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
- K Number
- K173871
- 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 Callisyn Biomedical Co., Ltd.
- Date Received
- December 20, 2017
- Decision Date
- September 17, 2018
- Product Code
- NAJ
- 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 |
|---|---|---|---|
| NAJ | Agents, Embolic, For Treatment Of Uterine Fibroids | FDA class 2 | Cardiovascular |
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