Medical Device Manufacturer · US , Mchenry , IL

Medical Components, Inc.

63 submissions · 55 cleared · Since 1980
63
Total
55
Cleared
0
Denied

Medical Components, Inc. — FDA 510(k) Submissions

Medical Components, Inc. has submitted 63 FDA 510(k) premarket notifications since 1980, of which 55 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, Catheter, Hemodialysis, Implanted, Catheter, Hemodialysis, Non-implanted, Catheter, Subclavian, Catheter, Intravascular, Diagnostic . Use the specialty filter in the sidebar to narrow results.

63 devices
1–25 of 63
14F Duo-Flow? Side X Side Double Lumen Catheter
K250836 · MPB Catheter, Hemodialysis,... · Gastroenterology & Urology
Aug 2025 145d
PRO-PICC WITH VALVE TECHNOLOGY
K141633 · LJS Catheter, Intravascular,... · General Hospital
Sep 2014 103d
MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
K132880 · FPA Set, Administration,... · General Hospital
Jan 2014 117d
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
K131687 · LJS Catheter, Intravascular,... · General Hospital
Aug 2013 67d
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · DYB Introducer, Catheter · Cardiovascular
Aug 2013 155d
5F DIGNITY CT TITANIUM PORT
K130923 · LJT Port & Catheter,... · General Hospital
Jul 2013 119d
VALVED TEARAWAY INTRODUCER GENERATION II
K124046 · DYB Introducer, Catheter · Cardiovascular
Jun 2013 154d
3F PRO-PICC
K123617 · LJS Catheter, Intravascular,... · General Hospital
May 2013 173d
VASU-PICC
K122423 · LJS Catheter, Intravascular,... · General Hospital
Dec 2012 125d
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
K121848 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Sep 2012 88d
DIGNITY POWER INJECTABLE TITANIUM PORT
K120281 · LJT Port & Catheter,... · General Hospital
Sep 2012 230d
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
K121383 · FJS Catheter, Peritoneal,... · Gastroenterology & Urology
Sep 2012 120d
MEDCOMP VASCU-PICC & MIDLINE CATHETERS
K121094 · LJS Catheter, Intravascular,... · General Hospital
Jun 2012 57d
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC
K120980 · LJS Catheter, Intravascular,... · General Hospital
May 2012 30d
2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
K120981 · LJS Catheter, Intravascular,... · General Hospital
May 2012 30d
HEMO-CATH 10F, HEMO-CATH 12.5F
K113487 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Mar 2012 107d
SPLIT CATH III
K111651 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Dec 2011 178d
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
K012562 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Feb 2002 184d
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
K994105 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Oct 2001 667d
MEDCOMP ASH SPLIT
K011576 · NFK Kit, Repair, Catheter,... · Gastroenterology & Urology
Jun 2001 30d
MEDCOMP ULTRA-FLOW CATHETER
K003207 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Jun 2001 242d
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
K010021 · FOZ Catheter, Intravascular,... · General Hospital
Feb 2001 51d
MEDCOMP Z-CATH
K003682 · LJS Catheter, Intravascular,... · General Hospital
Jan 2001 57d
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
K991320 · MPB Catheter, Hemodialysis,... · Gastroenterology & Urology
Nov 1999 205d
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT
K980438 · MPB Catheter, Hemodialysis,... · Gastroenterology & Urology
Jun 1999 491d
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