510(k) K983511 ยท MPB Catheter, Hemodialysis, Non-Implanted
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Jun 8, 1999 |
| Received | Oct 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983511
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106
AAC02107
AAC02108 Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15
DL 11/20
DL 9/15 Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24
. Hemodialysis catheter insertion kits Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow IJ Full Tray; MCDLT114IJ
MCDLT116IJ
MCDLT118IJ Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow Catheter Full Tray; MCDLT3500
MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow XTP Straight Full Set, RMS02105
RMS02108 Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY;
T3500
T4000
T4400
T4424 Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C
T94M T96M T98M Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp DUO FLOW CUSTOM TRAYS; TRAY #414
TRAY #415
TRAY #67 Terminated |
MPB | None listed |
| Jul 12, 2018 | Medical Components, Inc dba MedComp DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ;
RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE
RAULERSON Terminated |
MPB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.