510(k) K030502 ยท MSD Catheter, Hemodialysis, Implanted
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
| Applicant | Medcomp, Harleysville PA, US |
| Decision | Substantially Equivalent, May 20, 2003 |
| Received | Feb 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2015 | Medical Components, Inc dba MedComp Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III;
AngioDynamics product- Dura-Flow Catheter, Schon Terminated |
MSD | None listed |
| Jun 28, 2011 | Medical Components, Inc dba MedComp THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit
Product Usage: Hemodialysis catheter insertion kit Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.