|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
extension set
|
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
|
K896561 |
02/01/1990
|
extension set w/injection site
|
MEDFUSION SYSTEMS, INC.
|
K842984 |
10/16/1984
|
extension sets with and without filters
|
MEDICAL SUPPORT SYSTEMS
|
K890176 |
04/26/1989
|
ez administration set
|
Y
|
K931550 |
01/10/1994
|
female luer lock cap
|
MedSafety Solutions LLC
|
K200425 |
10/29/2020
|
fluid administration set - contrast manager
|
MERIT MEDICAL SYSTEMS, INC.
|
K961794 |
08/01/1996
|
freedom integrated syringe infusion system
|
Repro-Med Systems, Inc., dba KORU Medical Systems
|
K200176 |
12/15/2021
|
freedom60 infusion pump; high-flo subcutaneous needle sets; precision flow rate tubing; high-flo super26 subcutaneous needle sets; freedom60 pre-filled syringe adapter
|
Koru Medical Systems
|
K231918 |
11/03/2023
|
freedomedge syringe infusion system
|
Repro-Medical System, Inc., dba Koru Medical Systems
|
K214045 |
04/29/2022
|
freedomedge(r) syringe infusion system
|
Repro-Medical System, Inc., dba Koru Medical Systems
|
K211206 |
11/09/2021
|