510(k) K152980 ยท DRS Transducer, Blood-Pressure, Extravascular
Flo Trac sensor, Volume View sensor
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 19, 2016 |
| Received | Oct 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152980
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2023 | Edwards Lifesciences, LLC Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring. Open, Classified |
DRS | None listed |
| Nov 29, 2023 | Edwards Lifesciences, LLC Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring. Open, Classified |
DRS | None listed |
| Nov 29, 2023 | Edwards Lifesciences, LLC FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring. Open, Classified |
DRS | None listed |
| Nov 29, 2023 | Edwards Lifesciences, LLC FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring. Open, Classified |
DRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.