ClearanceBrief
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

CodeDeviceRecords
MPBCatheter, Hemodialysis, Non-Implanted12
NFKKit, Repair, Catheter, Hemodialysis10
LJTPort & Catheter, Implanted, Subcutaneous, Intravascular8
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days7
MSDCatheter, Hemodialysis, Implanted7
LFJCatheter, Subclavian5
NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted3
DQXWire, Guide, Catheter1
DYBIntroducer, Catheter1
PNDMidline Catheter1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 16, 2023K232945Trio-CT­® Triple Lumen Catheter w/ Curved Extensions
Medical Components, Inc. (dba MedComp)
NIE
Sep 3, 2020K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
Medical Components, Inc. (dba MedComp)
MSD
Apr 23, 2020K192807Duo-Flow Side x Side Double Lumen Catheter
Medical Components, Inc. (dba MedComp)
MPB
Jun 14, 2019K183219Trio-CT Triple Lumen Catheter
Medical Components, Inc. (dba MedComp)
NIE
Jul 5, 2018K18117512F Tri-Flow Triple Lumen Catheter
Medical Components, Inc. (dba MedComp)
NIE
May 17, 2018K17366715.5F 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, 2018K180567C3 Wave System
Medical Components, Inc. (dba MedComp)
LJS
Dec 6, 2017K170934C3 Wave System
Medical Components, Inc (Dba Medcomp_
LJS
Jul 25, 2017K170770CT Midline
Medical Components, Inc. (dba MedComp)
PND

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 8, 2021Medical 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
LJTK132177
Jul 27, 2020Medical Components, Inc dba MedComp
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Terminated
MSDK994105
Mar 13, 2019Medical 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
LFJK893439
Mar 13, 2019Medical 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
LFJK893439
Mar 13, 2019Medical 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
LFJK893439
Mar 13, 2019Medical Components, Inc dba MedComp
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Terminated
LFJK893439
Oct 1, 2018Medical Components, Inc dba MedComp
C3 Wave App, v. 2.0.5
Terminated
LJSK170934
Jul 12, 2018Medical 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
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
Terminated
MPBK842416
K983511
Feb 23, 2018Medical 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
NFKK022570
Feb 23, 2018Medical 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
NFKK022570
Feb 23, 2018Medical 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
NFKK022570
Feb 23, 2018Medical 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
NFKK022570
Feb 23, 2018Medical 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
NFKK022570
Feb 23, 2018Medical 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
NFKK022570
Feb 23, 2018Medical 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
NFKK981125
Feb 23, 2018Medical 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
NFKK022570
Feb 23, 2018Medical 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
NFKK022570
Feb 23, 2018Medical 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
NFKK022570
Nov 22, 2017Medical Components, Inc dba MedComp
8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
Terminated
LJTK132177
May 25, 2017Medical 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
LJTK132177
Mar 8, 2017Medical 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
LJTK132177
Jun 7, 2016Medical 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
DYBK130687
Apr 27, 2015Medical 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
LJTK000125
Mar 30, 2015Medical 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
MSDK030502
K111651 +1
Feb 10, 2015Medical 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
LFJK890029
K893439
Sep 4, 2014Medical 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
MSDK121848
Feb 28, 2013Medical 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
LJSK081904
Jun 26, 2012Medical 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
LJTK070003
May 18, 2012Medical 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
LJTK070003
Jun 28, 2011Medical Components, Inc dba MedComp
THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit
Terminated
MSDK030502
Aug 17, 2010Medical 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
LJTK070003
Nov 10, 2009Medical Components, Inc dba MedComp
Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits.
Terminated
MSDK971925
Sep 16, 2008Medical 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
LJSK053345
Sep 16, 2008Medical 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
DQXK031916
Oct 28, 2005Medical Components, Inc dba MedComp
Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4
Terminated
LJSK003682
Oct 28, 2005Medical Components, Inc dba MedComp
Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T
Terminated
LJSK003682
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