FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
K Number: K171118
·
Decision Aug 15, 2017
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
8
Review Days
123
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Basic Information
- Device Name
- Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
- K Number
- K171118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cair Lgl
- Date Received
- April 14, 2017
- Decision Date
- August 15, 2017
- 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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| K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000) | Sep 1, 2017 | Substantially Equivalent |
| K171132 | Carefusion NeutraClear Needle-free connector | Jul 31, 2017 | Substantially Equivalent |
| K133073 | CAIR DRIVE, NEUTRACLEAR | Mar 20, 2014 | Substantially Equivalent |