FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROCOIL EMBOLIC SYSTEM (HES)
K Number: K113457
·
Decision Dec 16, 2011
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
179
Applicant Total
56
Review Days
24
Basic Information
- Device Name
- HYDROCOIL EMBOLIC SYSTEM (HES)
- K Number
- K113457
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MICROVENTION, INC.
- Date Received
- November 22, 2011
- Decision Date
- December 16, 2011
- 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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