FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLU-VEN 01510
K Number: K790424
·
Decision Apr 30, 1979
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
14
Review Days
60
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Basic Information
- Device Name
- FLU-VEN 01510
- K Number
- K790424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Venospital, Inc.
- Date Received
- March 1, 1979
- Decision Date
- April 30, 1979
- 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 Venospital, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791130 | FLU-VEN TK-2 | Sep 4, 1979 | Substantially Equivalent |
| K791131 | FLU VEN TR-1 | Sep 4, 1979 | Substantially Equivalent |
| K790077 | BIOSTIL # 3884 | Apr 30, 1979 | Substantially Equivalent |
| K781186 | INFUSION, VENOTHIN 23 | Aug 10, 1978 | Substantially Equivalent |
| K781187 | INFUSION SET W/ INJECTION SITE, 23D-W | Aug 10, 1978 | Substantially Equivalent |
| K781185 | INFUSION SET W/ INJECTION SITE | Aug 10, 1978 | Substantially Equivalent |
| K781188 | INFUSION SET, VENOTHIN 25 | Aug 10, 1978 | Substantially Equivalent |
| K781184 | INFUSION SET, VENOTHIN 19 | Aug 10, 1978 | Substantially Equivalent |
| K781190 | INFUSION SET, VENOTHIN 21 | Aug 10, 1978 | Substantially Equivalent |
| K781189 | FLU VEN 0151 | Aug 10, 1978 | Substantially Equivalent |