510(k) K170204 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
FFR Link, FFR Signal Processing Module
| Applicant | Boston Scientific Corporation, Fremont CA, US |
| Decision | Substantially Equivalent, Mar 24, 2017 |
| Received | Jan 23, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170204
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2017 | Boston Scientific Corporation FFR Link-FFR Signal Processing Module, Material Number H7495551000
It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer) Terminated |
DRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.