FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
Matreneu Percutaneous Balloon Compression Kit
K Number: K220920
·
Decision Sep 7, 2022
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
33
Applicant Total
1
Review Days
161
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Basic Information
- Device Name
- Matreneu Percutaneous Balloon Compression Kit
- K Number
- K220920
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4535
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Shineyard Medical Device Co. , Ltd.
- Date Received
- March 30, 2022
- Decision Date
- September 7, 2022
- Product Code
- HAO
- 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 |
|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | FDA class 1 | Neurology |
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