FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Easi-Vue embolic microspheres System
K Number: K220567
·
Decision Sep 7, 2022
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
128
Applicant Total
2
Review Days
191
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Basic Information
- Device Name
- Easi-Vue embolic microspheres System
- K Number
- K220567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abk Biomedical, Inc.
- Date Received
- February 28, 2022
- Decision Date
- September 7, 2022
- Product Code
- KRD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 Abk Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K234123 | Easi-Vue® embolic microspheres System | Feb 13, 2024 | Substantially Equivalent |