FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES
K Number: K851236
·
Decision Jul 26, 1985
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
3
Review Days
121
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Basic Information
- Device Name
- HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES
- K Number
- K851236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Infarkem Corp.
- Date Received
- March 27, 1985
- Decision Date
- July 26, 1985
- Product Code
- FJK
- 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 |
|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FDA class 2 | Gastroenterology, Urology |
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