510(k) K170373 ยท DYB Introducer, Catheter
Flextra Steerable Introducer
| Applicant | Rhythm Xience, Inc. (Rxi), Eden Prairie MN, US |
| Decision | Substantially Equivalent, Feb 27, 2017 |
| Received | Feb 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2020 | Acutus Medical Inc Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly Terminated |
DYB | None listed |
| Apr 23, 2020 | Acutus Medical Inc Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly Terminated |
DYB | None listed |
| Apr 23, 2020 | Acutus Medical Inc Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly Terminated |
DYB | None listed |
| Apr 23, 2020 | Acutus Medical Inc Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.