510(k) K233983 ยท DYG Catheter, Flow Directed
Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
| Applicant | Edwards Lifesciences, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 27, 2024 |
| Received | Dec 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233983
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2026 | Becton, Dickinson and Company Swan-Ganz Pacing Catheter, Models: D200F7; Open, Classified |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.