FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE
K Number: K860449
·
Decision Feb 26, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
3
Review Days
22
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Basic Information
- Device Name
- MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE
- K Number
- K860449
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Top Corp.
- Date Received
- February 4, 1986
- Decision Date
- February 26, 1986
- 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 |
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