510(k) K812800 ยท KRB Probe, Thermodilution
FLOW-DIRECTED THERMODILUTION CATHETER
| Applicant | Sorensen Research, Walker MI, US |
| Decision | Substantially Equivalent, Oct 20, 1981 |
| Received | Oct 6, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812800
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Pentalumen TD Thermodilution Catheter, Sterile Terminated |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.