510(k) K971291 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
HEARTPORT ENDOARTERIAL RETURN CANNULA
| Applicant | Heartport, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Jun 17, 1997 |
| Received | Apr 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2013 | Edwards Lifesciences, LLC Edwards EndoReturn Arterial Cannula, model ER21B and ER23B
Product Usage:
The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector h 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 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.