FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WINGED INFUSION SET
K Number: K832622
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
71
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Basic Information
- Device Name
- WINGED INFUSION SET
- K Number
- K832622
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Top Surgical Manufacturers Co.
- Date Received
- August 4, 1983
- Decision Date
- October 14, 1983
- 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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Other Clearances by Top Surgical Manufacturers Co.
| K Number | Device Name | ||
|---|---|---|---|
| K844343 | TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE | Jan 8, 1985 | Substantially Equivalent |
| 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 |
| K832621 | TOP DISPOSABLE PLASTIC SYRINGES | Oct 14, 1983 | Substantially Equivalent |