KSB · Set, Transfer (Blood/Plasma)
Hematology · 21 CFR 864.9875 · Class 2
Overview
| Product Code | KSB |
|---|---|
| Device Name | Set, Transfer (Blood/Plasma) |
| Regulation | 21 CFR 864.9875 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A transfer set is a device intended for medical purposes that consists of a piece of tubing with suitable adaptors used to transfer blood or plasma from one container to another.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Kawasumi Laboratories, Inc. | Sep 28, 2018 | SESE |
| K001043 | KAWASUMI LABORATORY BLOOD DRAWING KIT | Kawasumi Laboratories America, Inc. | May 19, 2000 | SESE |
| K820447 | ALPHA PLASMA TRANSFER SET | Alpha Therapeutic Corp. | Apr 14, 1982 | SESE |
| K802940 | SUPER-SPIKE TRANSFER SET | Geneva Laboratories, Inc. | Jan 15, 1981 | SESE |
| K791131 | FLU VEN TR-1 | Venospital, Inc. | Sep 4, 1979 | SESE |
| K791130 | FLU-VEN TK-2 | Venospital, Inc. | Sep 4, 1979 | SESE |
Top Applicants
- Venospital, Inc. — 2 clearances
- Alpha Therapeutic Corp. — 1 clearance
- Geneva Laboratories, Inc. — 1 clearance
- Kawasumi Laboratories America, Inc. — 1 clearance
- Kawasumi Laboratories, Inc. — 1 clearance
