KSB — Set, Transfer (Blood/Plasma) Class II
FDA product code KSB covers "Set, Transfer (Blood/Plasma)", a Class II medical device regulated under 21 CFR 864.9875. Submissions are reviewed by the Hematology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KSB
- Device Class
- Class II
- Regulation Number
- 864.9875
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172957 | kawasumi laboratories | Kawasumi Laboratories Blood Drawing Kit (BDK) System | September 28, 2018 |
| K001043 | kawasumi laboratories america | KAWASUMI LABORATORY BLOOD DRAWING KIT | May 19, 2000 |
| K820447 | alpha therapeutic | ALPHA PLASMA TRANSFER SET | April 14, 1982 |
| K802940 | geneva laboratories | SUPER-SPIKE TRANSFER SET | January 15, 1981 |
| K791131 | venospital | FLU VEN TR-1 | September 4, 1979 |
| K791130 | venospital | FLU-VEN TK-2 | September 4, 1979 |