Company · US
Medical Components, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2026. Name variants (Inc, Corp, punctuation) are merged.
64510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 10 |
| MSD | Catheter, Hemodialysis, Implanted | 8 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 6 |
| LFJ | Catheter, Subclavian | 5 |
| DQO | Catheter, Intravascular, Diagnostic | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 |
| DQY | Catheter, Percutaneous | 2 |
| DYB | Introducer, Catheter | 2 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 2 |
| KNZ | Accessories, A-V Shunt | 2 |
| LFK | Catheter, Femoral | 2 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 |
| BYI | Percussor, Powered-Electric | 1 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 |
| BZW | Stethoscope, Esophageal | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| DXT | Injector And Syringe, Angiographic | 1 |
| FIE | Needle, Fistula | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K260080 | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler Medical Components, Inc. | LJS |
| Aug 12, 2025 | K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter Medical Components, Inc. | MPB |
| Sep 29, 2014 | K141633 | PRO-PICC WITH VALVE TECHNOLOGY Medical Components, Inc. | LJS |
| Jan 8, 2014 | K132880 | MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE Medical Components, Inc. | FPA |
| Aug 16, 2013 | K131687 | 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET Medical Components, Inc. | LJS |
| Aug 15, 2013 | K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER Medical Components, Inc. | DYB |
| Jul 31, 2013 | K130923 | 5F DIGNITY CT TITANIUM PORT Medical Components, Inc. | LJT |
| Jun 3, 2013 | K124046 | VALVED TEARAWAY INTRODUCER GENERATION II Medical Components, Inc. | DYB |
| May 15, 2013 | K123617 | 3F PRO-PICC Medical Components, Inc. | LJS |
| Dec 12, 2012 | K122423 | VASU-PICC Medical Components, Inc. | LJS |
| Sep 21, 2012 | K121848 | SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM Medical Components, Inc. | MSD |
| Sep 17, 2012 | K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT Medical Components, Inc. | LJT |
| Sep 5, 2012 | K121383 | PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) Medical Components, Inc. | FJS |
| Jun 6, 2012 | K121094 | MEDCOMP VASCU-PICC & MIDLINE CATHETERS Medical Components, Inc. | LJS |
| May 2, 2012 | K120981 | 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC Medical Components, Inc. | LJS |
| May 2, 2012 | K120980 | 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC Medical Components, Inc. | LJS |
| Mar 9, 2012 | K113487 | HEMO-CATH 10F, HEMO-CATH 12.5F Medical Components, Inc. | MSD |
| Dec 8, 2011 | K111651 | SPLIT CATH III Medical Components, Inc. | MSD |
| Feb 8, 2002 | K012562 | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER Medical Components, Inc. | MSD |
| Oct 3, 2001 | K994105 | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 Medical Components, Inc. | MSD |
| Jun 21, 2001 | K011576 | MEDCOMP ASH SPLIT Medical Components, Inc. | NFK |
| Jun 12, 2001 | K003207 | MEDCOMP ULTRA-FLOW CATHETER Medical Components, Inc. | MSD |
| Feb 23, 2001 | K010021 | MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S Medical Components, Inc. | FOZ |
| Jan 26, 2001 | K003682 | MEDCOMP Z-CATH Medical Components, Inc. | LJS |
| Nov 10, 1999 | K991320 | MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN Medical Components, Inc. | MPB |
| Jun 10, 1999 | K980438 | 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT Medical Components, Inc. | MPB |
| Jun 8, 1999 | K983511 | SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH Medical Components, Inc. | MPB |
| Apr 15, 1999 | K974236 | MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB Medical Components, Inc. | MPB |
| Feb 26, 1999 | K981125 | MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 Medical Components, Inc. | MSD |
| Dec 10, 1998 | K983412 | MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T Medical Components, Inc. | LJS |
| May 11, 1998 | K973561 | MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M Medical Components, Inc. | FOZ |
| Feb 23, 1998 | K971925 | MEDCOMP BIO-FLEX CS CATHETER (CS100) Medical Components, Inc. | MSD |
| Mar 21, 1996 | K960426 | MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER Medical Components, Inc. | GBW |
| Sep 25, 1995 | K923691 | TWIN SILICONE CATHETER Medical Components, Inc. | MPB |
| Feb 2, 1994 | K915490 | MEDCOMP PERITONEAL DIALYSIS CATHETERS Medical Components, Inc. | FJS |
| Aug 27, 1993 | K930539 | MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY Medical Components, Inc. | BSO |
| Feb 2, 1993 | K915423 | HEMO-CATH SILICONE ACCESS CATHETER Medical Components, Inc. | LFJ |
| Mar 15, 1991 | K905021 | ACETATE CONCENTRATES FOR HEMODIALYSIS Medical Components, Inc. | KPO |
| Jun 13, 1989 | K893439 | HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C Medical Components, Inc. | LFJ |
| Apr 17, 1989 | K890029 | HEMO-CATH SILICONE DOUBLE LUMEN CATHETER Medical Components, Inc. | LFJ |
| Dec 13, 1988 | K883899 | MANUAL PERCUSSOR CUPS Medical Components, Inc. | BYI |
| Oct 20, 1987 | K873344 | ESOPHAGEAL STETHOSCOPE W/THERMISTOR Medical Components, Inc. | BZT |
| Sep 29, 1986 | K863661 | MEDCOMP DISPOSABLE MANIFOLD SYSTEM Medical Components, Inc. | DTL |
| Aug 6, 1986 | K862771 | MEDCOMP C.A.V.H. CATHETER Medical Components, Inc. | LFK |
| Jul 2, 1986 | K860867 | DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS Medical Components, Inc. | DQO |
| Apr 8, 1986 | K860810 | MEDCOMP'S FEMORAL VEIN CATHETERS Medical Components, Inc. | LFK |
| Mar 31, 1986 | K854984 | CUP MONITORING KIT CVPK-14 Medical Components, Inc. | DQY |
| Feb 18, 1986 | K850861 | ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE Medical Components, Inc. | DXT |
| Feb 14, 1986 | K860155 | PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 Medical Components, Inc. | FKO |
| Jul 26, 1984 | K842416 | DUO FLOW CATHETER-MC 54 Medical Components, Inc. | KNZ |
Newest 50 of 64.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||