DUO FLOW CATHETER-MC 54— 510(k) K842416

Name: FDA 510(k) clearance K842416
Creator: U.S. Food and Drug Administration
Published: 1984-07-26

Substantially Equivalent

Medical Components, Inc.

FDA 510(k) clearance K842416 for DUO FLOW CATHETER-MC 54, Substantially Equivalent on 1984-07-26. Applicant: Medical Components, Inc.. Device class: 2.

Clearance details

Applicant: Medical Components, Inc.
Product code: Code KNZ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1984-06-20
Decision date: 1984-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K842039 — ARGON DUAL LUMEN HEMODIALYSIS, CATHETER1985-01-29
K844612 — ACUTE HEMODIALYSIS TRAYS1984-12-17
K842864 — VACCESS FEMORAL CANNULA1984-08-08
K841530 — DOUBLE LUMEN SUBLCAVIAN-FEMORAL1984-06-25
K841119 — TOPS DISPOS. INFUSION SET/HEMODIALYSIS1984-04-20

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Recalls naming K842416

K-number listed on FDA's recall record

Z-2932-2018 — Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108Class II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2933-2018 — Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15Class II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2934-2018 — Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kitsClass II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2935-2018 — Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJClass II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2936-2018 — Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kitsClass II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2937-2018 — Duo-Flow XTP Straight Full Set, RMS02105 RMS02108Class II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2938-2018 — Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119MClass II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2939-2018 — SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424Class II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2940-2018 — SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98MClass II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2941-2018 — DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67Class II·Terminated·Medical Components, Inc dba MedComp·20180712
Z-2942-2018 — 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 PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL, SYRINGE, AND NEEDLE, XTP118IJS-ID; DOUBLE LUMEN CATHETER WITH CURVED EXTENSIONS (CATHETER ONLY), XTP114IJC=, XTP116IJC=, DOUBLE LUMEN IJ CATHETER SET, XTP114IJS=, XTP115IJS=, XTP116IJS=, XTP116IJS=JO, DOUBLE LUMEN CATHETER SET, XTP114MT= DUO-FLOW DOUBLE LUMEN CATHETER, XTP116CT, INTERNAL JUGULAR CATHETER SET, XTP96IJS= (additional product codes/catalog numbers in attached spreadsheet)Class II·Terminated·Medical Components, Inc dba MedComp·20180712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K842416.

Data sourced from openFDA. This site is unofficial and independent of the FDA.