FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXEL AVF SINGLE NEEDLE
K Number: K963658
·
Decision May 5, 1998
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
18
Review Days
609
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Basic Information
- Device Name
- EXEL AVF SINGLE NEEDLE
- K Number
- K963658
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Exel Intl.
- Date Received
- September 3, 1996
- Decision Date
- May 5, 1998
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Exel Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K992290 | EXEL INJECTION PLUG WITH CAP | Feb 23, 2000 | Substantially Equivalent |
| K963659 | EXEL I.V. ADMINISTRATION SET | Dec 16, 1997 | Substantially Equivalent |
| K926119 | EXEL HUBER INFUSION SET ROTATING WING | Aug 11, 1993 | Substantially Equivalent |
| K904685 | EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) | Nov 21, 1990 | Substantially Equivalent |
| K903945 | EXEL A-V FISTULA SET | Nov 20, 1990 | Substantially Equivalent |
| 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 |
| K895769 | EXEL HUBER NEEDLE | Feb 16, 1990 | Substantially Equivalent |