Medisystems Corp.
Medical device manufacturer in Lawrence, MA.
22510(k) clearances
0PMA approvals
1recalls
Device types
- FIE Needle, Fistula 6
- KOC Accessories, Blood Circuit, Hemodialysis 5
- FIB Protector, Transducer, Dialysis 3
- FPA Set, Administration, Intravascular 2
- FJK Set, Tubing, Blood, With And Without… 2
- FMI Needle, Hypodermic, Single Lumen 2
- FJI Dialyzer, Capillary, Hollow Fiber 1
- KDJ Set, Administration, For Peritoneal… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K062953 | Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceFIE · Traditional | 02/12/2007SE |
| K010279 | Medisystems Luer Access Injection SiteFPA · Traditional | 05/29/2001SE |
| K002372 | Access Alert GaugeKOC · Traditional | 10/25/2000SE |
| K994306 | ReversoKOC · Traditional | 03/20/2000SE |
| K990803 | Medisystems Buttonhole Needle SetsFIE · Traditional | 01/06/2000SE |
| K983076 | Medisystems Transducer ProtectorFIB · Traditional | 11/25/1998SE |
| K971860 | Medisystems Dialysis Priming SetsKOC · Traditional | 08/18/1997SE |
| K963668 | Medisystems Peritoneal Dialysis SetsKDJ · Traditional | 08/15/1997SE |
| K970536 | Medisystems Tranducer ProtectorFIB · Traditional | 05/12/1997SE |
| K953823 | Arterial Venous Blood Tubing SetFJK · Traditional | 09/23/1996SE |
| K932074 | Medisystems Apheresis Needle with GuardFIE · Traditional | 02/18/1994SE |
| K910734 | Medisystems Hemodialysis Fistula SetFIE · Traditional | 06/20/1991SE |
| K910733 | Medisystems Anti-Stick Injection Site NeedleFMI · Traditional | 06/06/1991SE |
| K895856 | Medisystems Transducer ProtectorFIB · Traditional | 11/24/1989SE |
| K862002 | Medisystems Pheresis NeedleFIE · Traditional | 06/27/1986SE |
| K823068 | Medisystems Fistula NeedlesKOC · Traditional | 01/26/1983SE |
| K823069 | Kf-E Series Hollow Fiber DialyzerKOC · Traditional | 01/21/1983SE |
| K812910 | Medisystems Needles & SyringesFMI · Traditional | 11/06/1981SE |
| K812353 | Kf-E Series of Hollow Fiber DialyzersFJI · Traditional | 09/16/1981SE |
| K811839 | Medisystem Negative PressureFJK · Traditional | 09/08/1981SE |
| K811838 | Medisystems Fistula NeedleFIE · Traditional | 09/08/1981SE |
| K811837 | I.V. Administration SetFPA · Traditional | 07/10/1981SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1126-2012 | Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard…Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly… | 01/31/2012Terminated |