510(k) K791130
- Device
- FLU-VEN TK-2
- Applicant
- VENOSPITAL, INC.
- 510(k) number
- K791130
- Product code
- KSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-09-04
- Date received
- 1979-06-18
- Regulation
- 864.9875
- Classification name
- Set, Transfer (blood/plasma)
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010413216
- 1018470
- 1722028
- 3004634229
- 9681835
- 9615908
- 3004201275
- 1058584
- 1000163068
- 3004548776
- 1066733
- 9710609
- 9612051
- 3037389071
- 1319639
- 1055927
- 2248588
- 3010432890
- 8010026
- 1061124
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KSB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Kawasumi Laboratories, Inc. | 2018-09-28 |
| K001043 | KAWASUMI LABORATORY BLOOD DRAWING KIT | Kawasumi Laboratories America, Inc. | 2000-05-19 |
| K820447 | ALPHA PLASMA TRANSFER SET | Alpha Therapeutic Corp. | 1982-04-14 |
| K802940 | SUPER-SPIKE TRANSFER SET | Geneva Laboratories, Inc. | 1981-01-15 |
| K791131 | FLU VEN TR-1 | Venospital, Inc. | 1979-09-04 |
Legacy Summary#
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FDA Review#
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