510(k) K190628 ยท DYB Introducer, Catheter
FlexSeal Introducer Sheath with Hydrophilic Coating
| Applicant | Freudenberg Medical Mis, Inc., Jeffersonville IN, US |
| Decision | Substantially Equivalent, May 30, 2019 |
| Received | Mar 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190628
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2022 | Freudenberg Medical, Llc Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm
Model: 668782-100 (US) Terminated |
DYB | None listed |
| Feb 21, 2022 | Freudenberg Medical, Llc Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm
Model: 668782-200 (OUS) Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.