510(k) K181031 ยท DYB Introducer, Catheter
TSI Transseptal Introducer
| Applicant | Pressure Products Medical Device Manufacturing, LLC, Morton PA, US |
| Decision | Substantially Equivalent, Oct 26, 2018 |
| Received | Apr 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181031
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.