|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
infusion sets for single use
|
Sichuan Prius Biotechnology Co., Ltd.
|
K221075 |
11/21/2022
|
infusion sets for single use with needles
|
Sichuan Prius Biotechnology Co., Ltd.
|
K221069 |
11/21/2022
|
intravenous needles for single use,safety intravenous needles for single use
|
Sichuan Prius Biotechnology Co., Ltd.
|
K221078 |
11/21/2022
|
3m curos tamper-evident device, 3m curos tamper-evident device, large
|
3M Company
|
K220507 |
05/23/2022
|
freedomedge syringe infusion system
|
Repro-Medical System, Inc., dba Koru Medical Systems
|
K214045 |
04/29/2022
|
safety blood collection / infusion set (with/without needle holder), blood collection / infusion set (with/without needle holder)
|
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
|
K214075 |
04/12/2022
|
infusion sets for single use
|
Jiangsu Suyun Medical Materials Co., Ltd.
|
K202437 |
03/25/2022
|
bd vacutainer ultratouch push button blood collection set
|
Becton, Dickinson and Company
|
K212724 |
02/04/2022
|
freedom integrated syringe infusion system
|
Repro-Med Systems, Inc., dba KORU Medical Systems
|
K200176 |
12/15/2021
|
freedomedge(r) syringe infusion system
|
Repro-Medical System, Inc., dba Koru Medical Systems
|
K211206 |
11/09/2021
|