FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
i-ED COIL System
K Number: K210638
·
Decision Mar 26, 2021
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
2
Review Days
23
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Basic Information
- Device Name
- i-ED COIL System
- K Number
- K210638
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kaneka Medical America, LLC
- Date Received
- March 3, 2021
- Decision Date
- March 26, 2021
- Product Code
- HCG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
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Other Clearances by Kaneka Medical America, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K213166 | Thrombuster II Aspiration Catheter | Oct 26, 2021 | Substantially Equivalent |