Company · US
Medical Components, Inc dba MedComp
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2023. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
46recalls (0 in 12 months)
46recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MPB | Catheter, Hemodialysis, Non-Implanted | 12 |
| NFK | Kit, Repair, Catheter, Hemodialysis | 10 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 8 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 7 |
| MSD | Catheter, Hemodialysis, Implanted | 7 |
| LFJ | Catheter, Subclavian | 5 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 3 |
| DQX | Wire, Guide, Catheter | 1 |
| DYB | Introducer, Catheter | 1 |
| PND | Midline Catheter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2023 | K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions Medical Components, Inc. (dba MedComp) | NIE |
| Sep 3, 2020 | K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes Medical Components, Inc. (dba MedComp) | MSD |
| Apr 23, 2020 | K192807 | Duo-Flow Side x Side Double Lumen Catheter Medical Components, Inc. (dba MedComp) | MPB |
| Jun 14, 2019 | K183219 | Trio-CT Triple Lumen Catheter Medical Components, Inc. (dba MedComp) | NIE |
| Jul 5, 2018 | K181175 | 12F Tri-Flow Triple Lumen Catheter Medical Components, Inc. (dba MedComp) | NIE |
| May 17, 2018 | K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Cat Medical Components, Inc. (dba MedComp) | MSD |
| Apr 12, 2018 | K180567 | C3 Wave System Medical Components, Inc. (dba MedComp) | LJS |
| Dec 6, 2017 | K170934 | C3 Wave System Medical Components, Inc (Dba Medcomp_ | LJS |
| Jul 25, 2017 | K170770 | CT Midline Medical Components, Inc. (dba MedComp) | PND |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2021 | Medical Components, Inc dba MedComp Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system. Open, Classified |
LJT | K132177 |
| Jul 27, 2020 | Medical Components, Inc dba MedComp Medcomp 15.SF X 24CM Titan HD CATHETER
(CUFF 19CM FROM TIP)
Ref: THD155024 Terminated |
MSD | K994105 |
| Mar 13, 2019 | Medical Components, Inc dba MedComp 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425
Product Usage: An aid for introducing a hemodialysis catheter Terminated |
LFJ | K893439 |
| Mar 13, 2019 | Medical Components, Inc dba MedComp 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424
Product Usage: An aid for introducing a hemodialysis catheter Terminated |
LFJ | K893439 |
| Mar 13, 2019 | Medical Components, Inc dba MedComp 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423
Product Usage: An aid for introducing a hemodialysis catheter Terminated |
LFJ | K893439 |
| Mar 13, 2019 | Medical Components, Inc dba MedComp 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422 Terminated |
LFJ | K893439 |
| Oct 1, 2018 | Medical Components, Inc dba MedComp C3 Wave App, v. 2.0.5 Terminated |
LJS | K170934 |
| 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 | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp DUO FLOW CUSTOM TRAYS; TRAY #414
TRAY #415
TRAY #67 Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C
T94M T96M T98M Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY;
T3500
T4000
T4400
T4424 Terminated |
MPB | K842416 K983511 |
| 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 | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow XTP Straight Full Set, RMS02105
RMS02108 Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow Catheter Full Tray; MCDLT3500
MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow IJ Full Tray; MCDLT114IJ
MCDLT116IJ
MCDLT118IJ Terminated |
MPB | K842416 K983511 |
| 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 | K842416 K983511 |
| 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 | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106
AAC02107
AAC02108 Terminated |
MPB | K842416 K983511 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp REPAIR KIT, REF RPK-01, UDI 884908039856
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimu Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairi Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extension Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairi Terminated |
NFK | K022570 |
| 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 | K981125 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairin Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp REPAIR KIT, REF ARA101, UDI 884908083637
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum Terminated |
NFK | K022570 |
| Feb 23, 2018 | Medical Components, Inc dba MedComp CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891
Product Usage:
The Medcomp Repair Kit is indicated for use in replacing damaged female her
connectors, clamps, or repairing extensions where there Terminated |
NFK | K022570 |
| Nov 22, 2017 | Medical Components, Inc dba MedComp 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter Terminated |
LJT | K132177 |
| May 25, 2017 | Medical Components, Inc dba MedComp 6.6F Plastic Dignity Low Profile CT Port W/Attachable ChronoFlex Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157
Product Usage:
Indicated for patient therapies requiring repeated acce Terminated |
LJT | K132177 |
| Mar 8, 2017 | Medical Components, Inc dba MedComp 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter
The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular Terminated |
LJT | K132177 |
| Jun 7, 2016 | Medical Components, Inc dba MedComp Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490
Product Usage:
The 2F and 3F Vascu-Sheath Tea Terminated |
DYB | K130687 |
| Apr 27, 2015 | Medical Components, Inc dba MedComp 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide r Terminated |
LJT | K000125 |
| 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 | K030502 K111651 +1 |
| Feb 10, 2015 | Medical Components, Inc dba MedComp Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH),
MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO Terminated |
LFJ | K890029 K893439 |
| Sep 4, 2014 | Medical Components, Inc dba MedComp Split Cath III Trays, 16F x 28CM
Product Usage:
The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients. Terminated |
MSD | K121848 |
| Feb 28, 2013 | Medical Components, Inc dba MedComp REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components
Product Usage: Power injectable infusion PICC insertion kits Terminated |
LJS | K081904 |
| Jun 26, 2012 | Medical Components, Inc dba MedComp MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter.
Power Injectable Implantable Infusion Port insertion kit. Terminated |
LJT | K070003 |
| May 18, 2012 | Medical Components, Inc dba MedComp 8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an impla Terminated |
LJT | K070003 |
| Jun 28, 2011 | Medical Components, Inc dba MedComp THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit
Product Usage: Hemodialysis catheter insertion kit Terminated |
MSD | K030502 |
| Aug 17, 2010 | Medical Components, Inc dba MedComp medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841. Terminated |
LJT | K070003 |
| 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 | K971925 |
| Sep 16, 2008 | Medical Components, Inc dba MedComp USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system. Terminated |
LJS | K053345 |
| Sep 16, 2008 | Medical Components, Inc dba MedComp CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other in Terminated |
DQX | K031916 |
| Oct 28, 2005 | Medical Components, Inc dba MedComp Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4 Terminated |
LJS | K003682 |
| Oct 28, 2005 | Medical Components, Inc dba MedComp Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T Terminated |
LJS | K003682 |