510(k) K010021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Feb 23, 2001 |
| Received | Jan 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010021
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.