510(k) K180567 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, Apr 12, 2018 |
| Received | Mar 5, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180567
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.