510(k) K831759 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
INTRACARDIA SUCKERS
| Applicant | Research Industries Corp., Walker MI, US |
| Decision | Substantially Equivalent, Aug 12, 1983 |
| Received | Jun 1, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Suction Wand, models S099 and S0998B
Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical Terminated |
DWF | None listed |
| Jul 9, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081.
Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart dur Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.