510(k) K170934 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
C3 Wave System
| Applicant | Medical Components, Inc (Dba Medcomp_, Harleysville PA, US |
| Decision | Substantially Equivalent, Dec 6, 2017 |
| Received | Mar 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170934
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2018 | Medical Components, Inc dba MedComp C3 Wave App, v. 2.0.5 Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.