510(k) K994253 ยท FMF Syringe, Piston
VACLOK SYRINGE
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Jan 5, 2000 |
| Received | Dec 17, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K994253
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2021 | MICROVENTION INC. Aspiration Syringe Kit, REF: MVSK60 Terminated |
FMF | None listed |
| Dec 2, 2010 | Merit Medical Systems, Inc. VACLOCK Syringe, 10ml, REF: VAC110, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMF | None listed |
| Dec 2, 2010 | Merit Medical Systems, Inc. VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMF | None listed |
| Dec 2, 2010 | Merit Medical Systems, Inc. Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMF | None listed |
| Dec 2, 2010 | Merit Medical Systems, Inc. Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
FMF | None listed |
| Jan 9, 2004 | Heartport Inc EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduct Terminated |
DWF | None listed |
| Jan 9, 2004 | Heartport Inc EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduct Terminated |
DWF | None listed |
| Jan 9, 2004 | Heartport Inc DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoCla Terminated |
DWF | None listed |
| Jan 9, 2004 | Heartport Inc SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoC Terminated |
DWF | None listed |
| Jan 9, 2004 | Heartport Inc Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042). Terminated |
DWF | None listed |
| Nov 19, 2003 | Merit Medical Systems, Inc VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60 ml VACLOF SYRINGE-FIXED MALE LUER ... MERIT MEDICAL''. Sterile if package is unopened or undamaged. Part #VAC160. Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.