Medical Components, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
63
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K25083614F Duo-Flow® Side X Side Double Lumen CatheterAugust 12, 2025
K141633PRO-PICC WITH VALVE TECHNOLOGYSeptember 29, 2014
K132880MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLEJanuary 8, 2014
K1316876F X 60CM TRIPLE PRO-LINE CT BASIC IR SETAugust 16, 2013
K1306872F & 3F VASCU-SHEATH TEARAWAY INTRODUCERAugust 15, 2013
K1309235F DIGNITY CT TITANIUM PORTJuly 31, 2013
K124046VALVED TEARAWAY INTRODUCER GENERATION IIJune 3, 2013
K1236173F PRO-PICCMay 15, 2013
K122423VASU-PICCDecember 12, 2012
K121848SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55September 21, 2012
K120281DIGNITY POWER INJECTABLE TITANIUM PORTSeptember 17, 2012
K121383PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)September 5, 2012
K121094MEDCOMP VASCU-PICC & MIDLINE CATHETERSJune 6, 2012
K1209812.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICCMay 2, 2012
K1209801.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICCMay 2, 2012
K113487HEMO-CATH 10F, HEMO-CATH 12.5FMarch 9, 2012
K111651SPLIT CATH IIIDecember 8, 2011
K012562MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETERFebruary 8, 2002
K994105HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40October 3, 2001
K011576MEDCOMP ASH SPLITJune 21, 2001