510(k) K971925 ยท MSD Catheter, Hemodialysis, Implanted
MEDCOMP BIO-FLEX CS CATHETER (CS100)
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Feb 23, 1998 |
| Received | May 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2009 | Medical Components, Inc dba MedComp Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box.
Hemodialysis catheter insertion kits. Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.