FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXEL THREE-WAY STOPCOCK
K Number: K862492
·
Decision Sep 25, 1986
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
18
Review Days
86
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Basic Information
- Device Name
- EXEL THREE-WAY STOPCOCK
- K Number
- K862492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Exel Intl.
- Date Received
- July 1, 1986
- Decision Date
- September 25, 1986
- Product Code
- FMG
- 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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | FDA class 2 | General Hospital |
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FDA 510(k)
FDA Class 2
·General Hospital
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| K895770 | EXEL HUBER INFUSION SET | Jul 19, 1990 | Substantially Equivalent |
| K895768 | EXEL SAFELET CATHETER | Feb 16, 1990 | Substantially Equivalent |
| K895772 | EXEL INDWELLING CATHETER | Feb 16, 1990 | Substantially Equivalent |
| K895771 | EXEL SPINAL NEEDLES | Feb 16, 1990 | Substantially Equivalent |