510(k) K100819 ยท DYB Introducer, Catheter
THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
| Applicant | Onset Medical Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 2, 2010 |
| Received | Mar 23, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100819
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2019 | Terumo Medical Corporation SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425,
STFI-1435,
STFI-1625,
STFI-1635,
STFI-1825,
STFI-1835,
STFI-1925,
STFI-1935,
STFI-2125,
STFI-2135
Product Usage:
The Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.