FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD SmartSite Needle-Free Connector
K Number: K223088
·
Decision Apr 7, 2023
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
34
Review Days
189
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Basic Information
- Device Name
- BD SmartSite Needle-Free Connector
- K Number
- K223088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Care Fusion
- Date Received
- September 30, 2022
- Decision Date
- April 7, 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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|---|---|---|---|
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| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle | Sep 11, 2017 | Substantially Equivalent |
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