FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇷 Türkiye
FlowArt Valve for Vial Access
K Number: K232987
·
Decision Jun 26, 2024
Classifications
1
FEI Numbers
176
Registration Numbers
176
Same Product Code
200
Applicant Total
1
Review Days
278
Basic Information
- Device Name
- FlowArt Valve for Vial Access
- K Number
- K232987
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Asset Medikal Tasarim Sanayi Ve Ticaret A.S.
- Date Received
- September 22, 2023
- Decision Date
- June 26, 2024
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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