CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
FDA 510(k) clearance K173871 · decided 2018-09-17
Clearance details
- K-number
- K173871
- Device name
- CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
- Applicant
- Suzhou Hengrui Callisyn Biomedical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-12-20
- Decision date
- 2018-09-17
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- NAJ
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.