Company ยท US
Medisystems Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2007. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FIE | Needle, Fistula | 7 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 5 |
| FIB | Protector, Transducer, Dialysis | 3 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 |
| FPA | Set, Administration, Intravascular | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2007 | K062953 | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE Medisystems Corp. | FIE |
| May 29, 2001 | K010279 | MEDISYSTEMS LUER ACCESS INJECTION SITE Medisystems Corp. | FPA |
| Oct 25, 2000 | K002372 | ACCESS ALERT GAUGE Medisystems Corp. | KOC |
| Mar 20, 2000 | K994306 | REVERSO Medisystems Corp. | KOC |
| Jan 6, 2000 | K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS Medisystems Corp. | FIE |
| Nov 25, 1998 | K983076 | MEDISYSTEMS TRANSDUCER PROTECTOR Medisystems Corp. | FIB |
| Aug 18, 1997 | K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS Medisystems Corp. | KOC |
| Aug 15, 1997 | K963668 | MEDISYSTEMS PERITONEAL DIALYSIS SETS Medisystems Corp. | KDJ |
| May 12, 1997 | K970536 | MEDISYSTEMS TRANDUCER PROTECTOR Medisystems Corp. | FIB |
| Sep 23, 1996 | K953823 | ARTERIAL VENOUS BLOOD TUBING SET Medisystems Corp. | FJK |
| Feb 18, 1994 | K932074 | MEDISYSTEMS APHERESIS NEEDLE WITH GUARD Medisystems Corp. | FIE |
| Jun 20, 1991 | K910734 | MEDISYSTEMS HEMODIALYSIS FISTULA SET Medisystems Corp. | FIE |
| Jun 6, 1991 | K910733 | MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE Medisystems Corp. | FMI |
| Nov 24, 1989 | K895856 | MEDISYSTEMS TRANSDUCER PROTECTOR Medisystems Corp. | FIB |
| Jun 27, 1986 | K862002 | MEDISYSTEMS PHERESIS NEEDLE Medisystems Corp. | FIE |
| Jan 26, 1983 | K823068 | MEDISYSTEMS FISTULA NEEDLES Medisystems Corp. | KOC |
| Jan 21, 1983 | K823069 | KF-E SERIES HOLLOW FIBER DIALYZER Medisystems Corp. | KOC |
| Nov 6, 1981 | K812910 | MEDISYSTEMS NEEDLES & SYRINGES Medisystems Corp. | FMI |
| Sep 16, 1981 | K812353 | KF-E SERIES OF HOLLOW FIBER DIALYZERS Medisystems Corp. | FJI |
| Sep 8, 1981 | K811839 | MEDISYSTEM NEGATIVE PRESSURE Medisystems Corp. | FJK |
| Sep 8, 1981 | K811838 | MEDISYSTEMS FISTULA NEEDLE Medisystems Corp. | FIE |
| Jul 10, 1981 | K811837 | I.V. ADMINISTRATION SET Medisystems Corp. | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 29, 2012 | Medisystems Corp 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 prote Terminated |
FIE | K910734 |