FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROPLEX COIL SYSTEM
K Number: K012145
·
Decision Oct 29, 2001
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
179
Applicant Total
56
Review Days
111
Basic Information
- Device Name
- MICROPLEX COIL SYSTEM
- K Number
- K012145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MICROVENTION, INC.
- Date Received
- July 10, 2001
- Decision Date
- October 29, 2001
- 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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| K133626 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 | Dec 20, 2013 | Substantially Equivalent |