FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLU VEN TR-1
K Number: K791131
·
Decision Sep 4, 1979
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
5
Applicant Total
14
Review Days
78
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FLU VEN TR-1
- K Number
- K791131
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9875
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Venospital, Inc.
- Date Received
- June 18, 1979
- Decision Date
- September 4, 1979
- Product Code
- KSB
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KSB | Set, Transfer (Blood/Plasma) | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KSB), ordered by most recent decision date.
Kawasumi Laboratories Blood Drawing Kit (BDK) System
FDA 510(k)
FDA Class 2
·Hematology
KAWASUMI LABORATORY BLOOD DRAWING KIT
FDA 510(k)
FDA Class 2
·Hematology
ALPHA PLASMA TRANSFER SET
FDA 510(k)
FDA Class 2
·Hematology
SUPER-SPIKE TRANSFER SET
FDA 510(k)
FDA Class 2
·Hematology
FLU-VEN TK-2
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Venospital, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791130 | FLU-VEN TK-2 | Sep 4, 1979 | Substantially Equivalent |
| K790077 | BIOSTIL # 3884 | Apr 30, 1979 | Substantially Equivalent |
| K790424 | FLU-VEN 01510 | 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 |