510(k) K981125 ยท MSD Catheter, Hemodialysis, Implanted
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Feb 26, 1999 |
| Received | Mar 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981125
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairin Terminated |
NFK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.