Product code KSB
- Device name
- Set, Transfer (Blood/Plasma)
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9875
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K791130 | FLU-VEN TK-2 | Venospital, Inc. | 1979-09-04 |
| K791131 | FLU VEN TR-1 | Venospital, Inc. | 1979-09-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 35020583260314 | SCD Welding Wafer | TERUMO BCT, INC. | 2025-05-14 |
| 14052682004169 | Fenwal Plasma Transfer Sets with Two Spikes | Fresenius Kabi AG | 2018-05-29 |
| 00817827026126 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026010 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026027 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026034 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026041 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026058 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026065 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026072 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026089 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026096 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026102 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 00817827026119 | Advect™ | CHARTER MEDICAL, LTD. | 2018-04-10 |
| 14052682004268 | Fenwal Plasma Transfer Sets with Spike and Male Luer Adapter | Fresenius Kabi AG | 2018-03-26 |
| 00817827021138 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021152 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021145 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021121 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021114 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021091 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021084 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021077 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021060 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021053 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021046 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827021022 | N/A | CHARTER MEDICAL, LTD. | 2016-09-23 |
| 10811137010650 | NA | FENWAL, INC. | 2016-09-12 |
| 00811137012695 | NA | FENWAL, INC. | 2016-09-12 |
| 10811137010704 | NA | FENWAL, INC. | 2016-09-12 |