510(k) K152498 ยท DYB Introducer, Catheter
SoloPath Re-Collapsible Access System
| Applicant | Onset Medical Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 5, 2016 |
| Received | Sep 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2019 | Terumo Medical Corporation SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925,
SR-1935,
SR-2025,
SR-2035,
SR-2225,
SR-2235,
SR-2425,
SR-2435 Terminated |
DYB | None listed |
| May 28, 2019 | Terumo Medical Corporation Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19,
PRTSOLO-20 Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.