FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
K Number: K844343
·
Decision Jan 8, 1985
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
12
Review Days
60
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Basic Information
- Device Name
- TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
- K Number
- K844343
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Top Surgical Manufacturers Co.
- Date Received
- November 9, 1984
- Decision Date
- January 8, 1985
- 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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FDA Class 2
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DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
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·Gastroenterology, Urology
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 Top Surgical Manufacturers Co.
| K Number | Device Name | ||
|---|---|---|---|
| K843415 | TOP HYPODERMIC SYRINGE LUER LOCK | Dec 7, 1984 | Substantially Equivalent |
| K843313 | TOP DISPOSABLE SPINAL NEEDLE | Sep 19, 1984 | Substantially Equivalent |
| K843414 | TOP HYPODERMIC SYRINGE PISTON | Sep 7, 1984 | Substantially Equivalent |
| K841119 | TOPS DISPOS. INFUSION SET/HEMODIALYSIS | Apr 20, 1984 | Substantially Equivalent |
| K841025 | TOP DISPOSABLE INFUSION SET | Mar 30, 1984 | Substantially Equivalent |
| K832624 | TOP VENULA I.V. CATHETER SET | Nov 21, 1983 | Substantially Equivalent |
| K832625 | TOP THREE WAY STOPCOCK | Oct 19, 1983 | Substantially Equivalent |
| K832626 | TOP STERILE DISPOS. HYPODERMIC NEEDLES | Oct 14, 1983 | Substantially Equivalent |
| K832622 | WINGED INFUSION SET | Oct 14, 1983 | Substantially Equivalent |
| K832621 | TOP DISPOSABLE PLASTIC SYRINGES | Oct 14, 1983 | Substantially Equivalent |