FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMODIALYSIS VENOUS & ARTERIAL SET
K Number: K812622
·
Decision Sep 24, 1981
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
2
Review Days
9
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Basic Information
- Device Name
- HEMODIALYSIS VENOUS & ARTERIAL SET
- K Number
- K812622
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Amisco Trading Corp.
- Date Received
- September 15, 1981
- Decision Date
- September 24, 1981
- Product Code
- FKH
- 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 |
|---|---|---|---|
| FKH | Solution-Test Standard-Conductivity, Dialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Other Clearances by Amisco Trading Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K812621 | DELTA-A.V. FISTULA CANNULATION SET | Sep 24, 1981 | Substantially Equivalent |