510(k) K994105 ยท MSD Catheter, Hemodialysis, Implanted
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Oct 3, 2001 |
| Received | Dec 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994105
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2020 | Medical Components, Inc dba MedComp Medcomp 15.SF X 24CM Titan HD CATHETER
(CUFF 19CM FROM TIP)
Ref: THD155024 Terminated |
MSD | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.