FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXEL A-V FISTULA SET
K Number: K903945
·
Decision Nov 20, 1990
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
18
Review Days
85
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Basic Information
- Device Name
- EXEL A-V FISTULA SET
- K Number
- K903945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Exel Intl.
- Date Received
- August 27, 1990
- Decision Date
- November 20, 1990
- Product Code
- FIE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
JMS CAVEO A.V. Fistula Needle Set
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DORA Disposable A.V. Fistula Needle Sets
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Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
FDA 510(k)
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DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JMS Harmony A.V. Fistula Needle Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Exel Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K992290 | EXEL INJECTION PLUG WITH CAP | Feb 23, 2000 | Substantially Equivalent |
| K963658 | EXEL AVF SINGLE NEEDLE | May 5, 1998 | 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 |
| 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 |