FDA.reportPublic FDA data

MEDICAL COMPONENTS INC

Matched from indexed company URL: Medical Components, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25189022518902MEDICAL COMPONENTS INC1N2026-01-011499 DELP DRIVE HARLEYSVILLE PA US 19438
30137501253013750125Medical Components, Inc.1Y2026-01-013088 East 33rd Place Yuma AZ US 85365

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00884908016901GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIRE - "0.018"" (0.46MM) X 130CM NITINOL GUIDEWIRE W/ RADIOPAQUE TIP"+1(215)256-4201clinical@medcompnet.com
00884908105254GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIRE - 0.010 (0.26MM) X 20CM0.010 (0.26 NITINOL GUIDEWIRENITINOL GUIDEWI+1(215)256-4201clinical@medcompnet.com
00884908105278GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIRE - "0.010"" (0.26MM) X 40CM0.010"" (0. NITINOL GUIDEWIRENITINOL GUIDEWI"+1(215)256-4201clinical@medcompnet.com
00884908136630DUO-FLOW® SIDE X SIDE - 14F X 15CM DUO-FLOW® SIDE X SIDE DOUBLE LUMEN CATHETER BASIC SET+1(215)256-4201clinical@medcompnet.com
00884908136647DUO-FLOW® SIDE X SIDE - 14F X 20CM DUO-FLOW® SIDE X SIDE DOUBLE LUMEN CATHETER BASIC SET+1(215)256-4201clinical@medcompnet.com
00884908136654DUO-FLOW® SIDE X SIDE - 14F X 24CM DUO-FLOW® SIDE X SIDE DOUBLE LUMEN CATHETER BASIC SET+1(215)256-4201clinical@medcompnet.com
00884908136661DUO-FLOW® SIDE X SIDE - 14F X 15CM DUO-FLOW® SIDE X SIDE DOUBLE LUMEN CURVED EXTENSION CATHETER BASIC SET+1(215)256-4201clinical@medcompnet.com
00884908145090GALT GUIDEWIREGALT GUIDEWIRE - "0.010"" (0.26MM) X 40CM0.010"" (0. NITINOL GUIDEWIRENITINOL GUIDEWI"+1(215)256-4201clinical@medcompnet.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
77271418745056K994105HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40MSD2001-10-03
2290661418745056K994105HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40MSD2001-10-03
77271034762523K983511SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATHMPB1999-06-08
77271814048937K981125MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6MSD1999-02-26
77271729225167K98043811.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MTMPB1999-06-10
77271864109619K974236MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SBMPB1999-04-15
77271969237427K973561MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1MFOZ1998-05-11
77271578236559K972207MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CMMSD1998-02-23
77271530064795K971925MEDCOMP BIO-FLEX CS CATHETER (CS100)MSD1998-02-23
77271841527848K971281RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLEDQX1997-10-09
77271612064422K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
77271062939698K923691TWIN SILICONE CATHETERMPB1995-09-25
77271218672919K915490MEDCOMP PERITONEAL DIALYSIS CATHETERSFJS1994-02-02
77271107070901K915423HEMO-CATH SILICONE ACCESS CATHETERLFJ1993-02-02
77271872486268K893439HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40CLFJ1989-06-13
77271448012398K890029HEMO-CATH SILICONE DOUBLE LUMEN CATHETERLFJ1989-04-17
77271748891739K862771MEDCOMP C.A.V.H. CATHETERLFK1986-08-06
77271610836339K860810MEDCOMP'S FEMORAL VEIN CATHETERSLFK1986-04-08
77271126914408K851834MANAN GWI GUIDE WIRE INTRODUCERDWS1985-07-11
2290661126914408K851834MANAN GWI GUIDE WIRE INTRODUCERDWS1985-07-11
77271906154505K842416DUO FLOW CATHETER-MC 54KNZ1984-07-26
77271049403322K841530DOUBLE LUMEN SUBLCAVIAN-FEMORALKNZ1984-06-25
77271471500638K840175DOUBLE LUMEN INFUSION CATHETERSDQY1984-02-10
77271981346102K834615TRIPLE LUMEN INFUSIONCATHETERS-JCY1984-02-14
77271487812042K821684MCSCP8PS WITH 'Y' HUBLFJ1982-06-24
77271184474284K801672MEDCOMP SUBCLAVIAN CATHETERLFJ1980-12-18
77271207659375K800741CENTRAL VEIN CATHETERIZATION KITDQO1980-04-16
77271398834547K800462PERCUTANEOUS INTRODUCER SETDRE1980-03-19
77272015837946K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
2290662015837946K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
77271844223560K25083614F Duo-Flow® Side X Side Double Lumen CatheterMPB2025-08-12
77271322838752K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsNIE2023-11-16
77271988456477K210461End CapMSD2021-09-14
77271258396995K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMSD2020-09-03
77271230080062K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetPTI2021-04-07
77271396043374K192807Duo-Flow Side x Side Double Lumen CatheterMPB2020-04-23
77271335755767K183219Trio-CT Triple Lumen CatheterNIE2019-06-14
77271348739730K18117512F Tri-Flow Triple Lumen CatheterNIE2018-07-05
77272057253439K180546Jet Power Injectable PICCLJS2018-11-21
77271239734811K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with SideholesMSD2018-05-17
77272036077604K171931Celerity ECG Cable Accessory PackLJS2017-10-26
77271150689076K171618Symetrex Long Term Hemodialysis CatheterMSD2017-11-16
77271273591414K171483ArchFlo CT MidlinePND2017-12-15
77271715642415K17133320G x 5/8 Pro-Lock CT Safety Infusion SetPTI2017-07-18
77271906294814K170770CT MidlinePND2017-07-25
77271674655910K162389Medcomp Vessel DilatorDRE2017-06-01
77271500588370K162271Pro-Lock CT Safety Infusion SetPTI2017-04-26
77271510830525K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeNGT2017-02-02
77271044434836K153246PTFE Super Sheath Introducer 2.1DYB2016-02-12
77271443500367K153238Dignity Dual PortLJT2016-03-15
77271170567466K142889Celerity PICC Tip Confirmation SystemLJS2015-01-27
77271103210324K141633PRO-PICC WITH VALVE TECHNOLOGYLJS2014-09-29
77271615850879K141151CT MIDLINELJS2014-07-08
77271916431994K140884SYMETREX LONG TERM HEMODIALYSIS CATHETERMSD2014-11-26
77271513898914K140799CELERITY SYSYEMLJS2014-06-13
77271714598716K132880MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLEFPA2014-01-08
77271959093252K132498VALVED TEARAWAY INTRODUCER GENERATION IIDYB2013-11-25
77271970091473K132177MEDCOMP GEN III POWER INJECTABLE PORTLJT2013-12-12
77271474848729K1316876F X 60CM TRIPLE PRO-LINE CT BASIC IR SETLJS2013-08-16
77271542607073K1309235F DIGNITY CT TITANIUM PORTLJT2013-07-31
77271781343044K130897MEDCOMP VASCU-PICC WITH VALVELJS2013-10-22
77271420190615K130889SPLIT CATH RGMSD2014-04-28
77271136627472K130855PTFE SUPER SHEATH INTRODUCERDYB2013-07-29
77271407205450K1306872F & 3F VASCU-SHEATH TEARAWAY INTRODUCERDYB2013-08-15
77271675236490K124046VALVED TEARAWAY INTRODUCER GENERATION IIDYB2013-06-03
77271362058838K1236173F PRO-PICCLJS2013-05-15
77271654542126K123292T3NIE2013-06-11
77271964447644K122423VASU-PICCLJS2012-12-12
77271468963992K121848SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CMMSD2012-09-21
77271093508230K121383PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)FJS2012-09-05
77271450759260K121094MEDCOMP VASCU-PICC & MIDLINE CATHETERSLJS2012-06-06
77271710389112K1209812.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICCLJS2012-05-02
77271738138776K1209801.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICCLJS2012-05-02
77271041055014K120617PTFE SUPER SHEATH INTRODUCERDYB2012-11-19
77271919510770K120281DIGNITY POWER INJECTABLE TITANIUM PORTLJT2012-09-17
77271113167804K113487HEMO-CATH 10F, HEMO-CATH 12.5FMSD2012-03-09
77271863784473K111651SPLIT CATH IIIMSD2011-12-08
77271064823569K110424DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFILLJT2011-11-30
77271269574838K1029662.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICCLJS2010-12-21
77272009050837K093309PRO-LINE CT (BASIC TRAY) MODEL MR28036101LJS2009-11-24
77271430699299K092347PRO-PICC CTLJS2009-09-16
77271670944087K091954MICRO-STICK SETDYB2010-01-08
77271822425084K091953PRO-PICCLJS2009-09-16
2290661822425084K091953PRO-PICCLJS2009-09-16
77271632517314K091586VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMENLJS2009-07-23
77271052892576K0914661.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50LJS2009-06-17
77271148133232K090394VALVED TEARWAY INTRODUCERDYB2009-09-01
77271925217129K081904PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)LJS2008-09-23
77271180451331K081775THE MEDCOMP .010 VASCULAR GUIDEWIRESDQX2009-03-25
77271911635297K080544UNASSIGNEDFPA2008-08-14
77271422873798K072509PRO-PICC, BASIC TRAY; LONG WIRE TRAY; BASIC NURSING TRAY; FULL NURSING TRAYLJS2007-11-26
77271791152523K070150VASCUPUNCTURE PICC GUIDEWIREDQX2007-02-15
77271878640854K070003POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)LJT2007-05-15
77271401488743K0619861.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50LJS2006-08-03
77271840961958K053345PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6DLJS2006-03-17
77271113040445K053092MEDCOMP VASCU-SHEATH IIDYB2006-08-01
77272046120664K051280MEDCOMP SPLIT CATH IIMSD2005-11-30
2290662046120664K051280MEDCOMP SPLIT CATH IIMSD2005-11-30
77271029414487K043398MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIREDQX2005-03-01
77271011051064K04099215F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706MSD2004-07-29
77271299381398K04032815.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETERMSD2004-11-24
77271589237882K040318MEDCOMP SPLIT-CATH IIMSD2005-02-03
77271634370059K033570MEDCOMP T-3NIE2004-09-16
77271357276299K031652VASCUPUNCTURE PICC GUIDEWIREDQX2003-09-30
77272060157262K030636C-PORTLJT2003-06-05
2290662060157262K030636C-PORTLJT2003-06-05
77271599431917K03050214.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55MSD2003-05-20
77271529311062K0302703F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICONLJS2003-04-11
77271873084333K022678MEDCOMP SC4MSD2003-02-24
77271671387133K022570MEDCOMP REPAIR KIT, MODEL ASPCRPKNFK2002-10-31
77271077657186K022513MEDCOMP VASCU-SHEATH INTRODUCER SETDYB2002-10-25
77272017350200K021990GALT MEDICAL GUIDEWIREDQX2002-07-18
77271440012019K02093610F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XLMSD2002-10-11
77271567227348K020465MEDCOMP ASH SPLIT-CATH IIMSD2002-05-22
77271884553176K02031514F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XLMSD2002-05-24
77271016966231K01316214F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASHKNT2001-10-19
77271732205994K012562MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETERMSD2002-02-08
2290661732205994K012562MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETERMSD2002-02-08
77271843924456K011576MEDCOMP ASH SPLITNFK2001-06-21
77271166219782K010306MEDCOMP EXCELL SPLIT TIP CATHETERMSD2001-10-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MSD272021-09-14
LJS272018-11-21
DYB102016-02-12
DQX92009-03-25
LJT82016-03-15
MPB62025-08-12
NIE52023-11-16
LFJ51993-02-02
PTI32021-04-07
PND22017-12-15
DRE22017-06-01
FPA22014-01-08
FJS22012-09-05
NFK22002-10-31
FOZ22001-02-23
LFK21986-08-06
DWS21985-07-11
KNZ21984-07-26
NGT12017-02-02
KNT12001-10-19
JCY11984-02-14
DQY11984-02-10
DQO11980-04-16

PMN#

End Cap

2021-09-14

Medical Components Inc (Medcomp)

CT Midline

2017-07-25

Medical Components, Inc. (dba Medcomp)

71 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next