510(k) K832957 ยท DYG Catheter, Flow Directed
FLOW-DIRECTED HEPARIN COATED THERMODIL
| Applicant | Sorensen Research, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 29, 1983 |
| Received | Aug 31, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832957
| 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.