FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Surflo Winged Infusion Set
K Number: K221411
·
Decision Jun 23, 2023
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
4
Review Days
403
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Basic Information
- Device Name
- Surflo Winged Infusion Set
- K Number
- K221411
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Medical Products (Hangzhou) Co., Ltd.
- Date Received
- May 16, 2022
- Decision Date
- June 23, 2023
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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