FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEGATIVE PRESSURE VENOUS BLOOD LINE
K Number: K833906
·
Decision Jan 3, 1984
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
181
Applicant Total
43
Review Days
50
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Basic Information
- Device Name
- NEGATIVE PRESSURE VENOUS BLOOD LINE
- K Number
- K833906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Erika, Inc.
- Date Received
- November 14, 1983
- Decision Date
- January 3, 1984
- Product Code
- KOC
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
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BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
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Other Clearances by Erika, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853134 | NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 | Nov 6, 1985 | Substantially Equivalent |
| K852310 | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK | Jul 26, 1985 | Substantially Equivalent |
| K852309 | ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 | Jul 26, 1985 | Substantially Equivalent |
| K850865 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1- | Apr 3, 1985 | Substantially Equivalent |
| K850866 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L | Apr 3, 1985 | Substantially Equivalent |
| K850655 | TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2 | Mar 7, 1985 | Substantially Equivalent |
| K850654 | TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID | Mar 7, 1985 | Substantially Equivalent |
| K842436 | ERIKA NEGATIVE PRESS. ARTERIAL BLOOD | Jul 13, 1984 | Substantially Equivalent |
| K831175 | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY | Jun 22, 1984 | Substantially Equivalent |
| K831173 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER | Jun 22, 1984 | Substantially Equivalent |