Medisystems Corp.
Seattle, WA, US
Medisystems Corp. appears in FDA device records in Seattle, WA. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for Medisystems Corp. between 1981 and 2007. The busiest year on record is 1981, with 5. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 5 |
| 1983 | 2 |
| 1986 | 1 |
| 1989 | 1 |
| 1991 | 2 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 1 |
| 2000 | 3 |
| 2001 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062953 | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE | FIE | Substantially Equivalent | |
| K010279 | MEDISYSTEMS LUER ACCESS INJECTION SITE | FPA | Substantially Equivalent | |
| K002372 | ACCESS ALERT GAUGE | KOC | Substantially Equivalent | |
| K994306 | REVERSO | KOC | Substantially Equivalent | |
| K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS | FIE | Substantially Equivalent | |
| K983076 | MEDISYSTEMS TRANSDUCER PROTECTOR | FIB | Substantially Equivalent | |
| K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS | KOC | Substantially Equivalent | |
| K963668 | MEDISYSTEMS PERITONEAL DIALYSIS SETS | KDJ | Substantially Equivalent | |
| K970536 | MEDISYSTEMS TRANDUCER PROTECTOR | FIB | Substantially Equivalent | |
| K953823 | ARTERIAL VENOUS BLOOD TUBING SET | FJK | Substantially Equivalent | |
| K932074 | MEDISYSTEMS APHERESIS NEEDLE WITH GUARD | FIE | Substantially Equivalent | |
| K910734 | MEDISYSTEMS HEMODIALYSIS FISTULA SET | FIE | Substantially Equivalent | |
| K910733 | MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE | FMI | Substantially Equivalent | |
| K895856 | MEDISYSTEMS TRANSDUCER PROTECTOR | FIB | Substantially Equivalent | |
| K862002 | MEDISYSTEMS PHERESIS NEEDLE | FIE | Substantially Equivalent | |
| K823068 | MEDISYSTEMS FISTULA NEEDLES | KOC | Substantially Equivalent | |
| K823069 | KF-E SERIES HOLLOW FIBER DIALYZER | KOC | Substantially Equivalent | |
| K812910 | MEDISYSTEMS NEEDLES & SYRINGES | FMI | Substantially Equivalent | |
| K812353 | KF-E SERIES OF HOLLOW FIBER DIALYZERS | FJI | Substantially Equivalent | |
| K811839 | MEDISYSTEM NEGATIVE PRESSURE | FJK | Substantially Equivalent | |
| K811838 | MEDISYSTEMS FISTULA NEEDLE | FIE | Substantially Equivalent | |
| K811837 | I.V. ADMINISTRATION SET | FPA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- FJIDialyzer, Capillary, Hollow Fiber
- FIENeedle, Fistula
- FMINeedle, Hypodermic, Single Lumen
- FIBProtector, Transducer, Dialysis
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- FPASet, Administration, Intravascular
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1126-2012 | Medisystems (a Nxstage Company) Hemodialysis Fistula Needle Set with MasterGuard Ant-Stick Needle Protector 15 GA x 1" Ref. Number: D9-2007MG. Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector. | Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain