510(k) K231248 ยท DYG Catheter, Flow Directed
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
| Applicant | Edwards Lifesciencess, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 21, 2023 |
| Received | May 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2026 | Becton, Dickinson and Company Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8; Open, Classified |
DYB | None listed |
| May 15, 2026 | Becton, Dickinson and Company Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P Open, Classified |
DYG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.