FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Numen Coil Embolization System; NumenFR Detachment System
K Number: K203625
·
Decision Sep 1, 2021
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
179
Applicant Total
3
Review Days
264
Basic Information
- Device Name
- Numen Coil Embolization System; NumenFR Detachment System
- K Number
- K203625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MicroPort NeuroTech (Shanghai) Co., Ltd.
- Date Received
- December 11, 2020
- Decision Date
- September 1, 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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