FDA.reportPublic FDA data

ARGON MEDICAL DEVICES INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16254251625425ARGON MEDICAL DEVICES INC.1N2026-01-011445 FLAT CREEK RD. ATHENS TX US 75751

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
224471471521865K991097PBN DRAINAGE CATHETER GUIDEWIRESKNY1999-04-23
224471636971969K990839TRU-CORE I REUSABLE BIOPSY INSTRUMENTKNW1999-05-20
224472018371061K990808PBN DILATORSFGE1999-11-26
224471998608935K983620MANAN SPINAL NEEDLESBSP1999-01-08
224471617440103K982960MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENTKNW1998-09-23
224471542404710K982085MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENTKNW1998-07-17
224471278783567K981956DEGANIA SILICONE IDENTI LOOPSDXC1998-07-09
224471179318104K980227MANAN GALACTOGRAPHY KITFMI1998-04-23
224471251767591K980226MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEMKNW1998-02-18
224471851401197K980196MD TECH BIOPSY SET FOR BONE AND BONE MARROWKNW1998-02-03
224471551367866K980122MANAN SOFT TISSUE BIOPSY NEEDLESKNW1998-01-30
224471157253390K980005MANAN D BAGEXF1998-01-30
224471166015909K980004MANAN GENERAL PURPOSE INTRODUCER NEEDLEKNW1998-01-09
224471109047571K974815MANAN(TM) INTRODUCER SHEATH/NEEDLEFGE1998-01-09
224471331960581K974814MANAN(TM) SUPER-CORE BIOPSY NEEDLESKNW1998-01-09
224471611752331K974766MANAN TECHNA-CUT ASPIRATION NEEDLEKNW1998-01-08
224471281060893K974745MANAN GWI GUIDE WIRE INTRODUCERDRC1998-04-06
224472066134298K974741MANAN ACCURA NEEDLEGAA1998-01-08
224471118370895K974543L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGERFOZ1998-02-10
224471980423229K974446MANAN AUTOMATIC CUTTING NEEDLEKNW1998-01-08
224471708315885K972263FIRST PICC CATHETER WITH DUAL LUMENSFOZ1997-09-15
224471942435896K972262FIRST PICC CATHETERFOZ1997-09-15
224471211041315K972254FIRST MIDCATH CATHETERFOZ1997-09-12
224471681178805K964050FIRST MIDCATH CATHETERFOZ1997-01-06
224471552156102K963749HIGH PRESSURE INJECTION LINESDTL1996-12-17
224471868639674K963388VESSEL DILATORDRE1997-03-11
224471487995028K953522USCI IDEAL PTCA KITMAV1996-04-17
224471133818280K951447DYNABITE CARDIOVASCULAR BIOPSY FORCEPSDWZ1995-07-27
224471624142325K951214STERILE EQUIPMENT COVERKKX1995-05-16
224471048985060K944522MORGANSTERN PROSTATE STABILIZATION AND SEEDING KITIWJ1995-02-24
224471655244606K921418ULTRA-CORE BIOPSY NEEDLESDWO1992-06-19
224471453624816K920755L-CATH PEEL AWAY SYSTEM CATHETERLJS1993-06-07
224471245288448K915301ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCKDTL1992-12-11
224471333286984K912172SAFEWEDGE(TM) RELIEF VALVE DEVICEKRB1991-09-27
224471853032556K911732ADVANCE DISPOSABLE CONTROL SYRINGEIZI1991-09-16
224471357037164K911710HEPARIN COATED THERMODILUTION CATH & ACCESSORIESDQO1991-10-23
224471286156002K904994CLOSED SYSTEM FLUSH SETDXT1991-01-15
224471814678769K904987VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD)KNW1991-02-11
224471420752647K894157OBTURATORDYB1989-09-28
224472009133720K891022INTRODUCER FOR PTCA GUIDING CATHETERSDYB1989-05-19
224471883915093K881957HAWKINS-AKINS BLUNT NEEDLE ACCESS KITKNW1988-05-20
224471710463269K880288TRU-TRAC TORQUE GUIDEWIREDQX1988-09-12
224471855074514K870523HAWKINS BREAST LOCALIZATION NEEDLEGDM1987-03-09
224471461791717K860307PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SETDYB1986-05-20
224471067572595K832030HEPARIN COATED STAINLESS STEEL/TEFLONDOX1983-09-29
224471884696438K821372DESERET INTRACATH INTRAVENOUS CATHETERFOZ1982-06-02
224471058914230K820883SEPTISLEEVEDYG1982-04-29
224471986233429K791098SINGLE-USE MINI-BULLDOGDXC1979-06-22
224471896112814K782006MEDGENERAL SINGLE-USE BULLDOGGDJ1978-12-15
224471495386720K781744IV SET WITH GRADUATED CHAMBERFPA1978-12-07
224471432676009K781579MODIFIED STERILE DISPOSABLE STOPCOCKSDTL1978-10-05
224471490405025K781558PRESSURE MONITORING INJECTION LINESDQO1978-10-10
224471663188522K781333CENTRAL CATHETER TRAYKGC1978-10-24
224471309614465K780871ARTERIAL LINE KITGDY1978-06-14
224471855704765K780673CENTRAL CATHETER KITFPK1978-05-16
224472031990259K780271COBE STOPCOCKDTL1978-03-02
224471853739090K780126DILATOR, VESSEL & INTRODUCER, SHEATHDRE1978-03-02
224471797278653K772369NEEDLES USED IN ANGIOGRAPHIC PROCED.DRC1978-01-24
224471228637442K771701VESSEL-CLUDEGDJ1977-12-13
224471625507496K770383STOPCOCK, ONE WAYKOC1977-03-07
224471490738500K253741V•Stick™ Vascular Access SetDYB2025-12-15
224471480364570K241145TLAB® Transvenous Liver Biopsy System (TF-18C)DYB2024-08-01
224472035511760K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration CanisterQEW2024-03-28
224471130633736K23343210F Sheath and Dilator SetDYB2023-12-08
224471219910624K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration CanisterQEW2024-01-19
224471804129831K231293Drakon™ and Sequre® MicrocathetersDQO2023-06-01
224471024240023K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersLJS2023-11-30
224471180296970K230631Kodiak™ Dual Port Coaxial Introducer KitDYB2023-05-22
224471110985621K213550HydroPICC 5F Dual Lumen CatheterLJS2022-05-04
224471274786717K213232NovaCore Semi-Automatic Biopsy InstrumentKNW2022-07-01
224471039787407K211798Cleaner Plus Thrombectomy SystemQEW2022-02-24
224471576218650K203487Drakon and Sequre MicrocathetersDQO2020-12-11
224472052177903K203069HydroMIDFOZ2021-02-08
224471463509589K202797Drakon and Sequre MicrocathetersDQO2020-10-23
224471311169801K202141Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetDYB2021-01-15
224471597521222K201489Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access setDYB2020-12-22
224471210794174K200963Halo Single-Loop Microsnare KitMMX2021-01-05
224471369183155K200268Halo™ Single-Loop Snare KitMMX2020-06-03
224472003256308K193015HydroPICC (PICC-142)LJS2020-02-20
224471598055237K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitMMX2019-12-17
224471108474447K173430SeQure® NF and SeQure® MicrocathetersDQO2018-01-26
224471906423868K160785Worker GuidewireDQX2016-12-08
224471956435259K143405Option (TM) ELITE Vena Cava Filter 100cm SystemDTK2015-04-16
224471929788386K141969FIRSTSTIC N INTRODUCERDYB2014-12-19
224471348143859K141617CLEANER ROTATIONAL THROMBECTOMY SYSTEMQEW2014-11-14
224472007167584K133243OPTION ELITE VENA CAVA FILTER SYSTEMDTK2013-12-17
224471935789085K130730V-STICK VASCULAR ACCESS SETDYB2013-11-22
224471168983798K120346CLEANER ROTATIONAL THROMBECTOMY SYSTEMMCW2012-06-01
224471632930569K102043ULTRASTREAM CHRONIC HEMODIALYSIS CATHETERMSD2010-11-18
224472031559056K091670BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETERLJS2009-07-01
224472069139263K091029CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)MCW2010-02-18
224471713467789K081410OPTION VENA CAVA FILTERDTK2009-06-04
224471447000760K073672SKATER BILIARY CATHETERFGE2008-01-24
224471374786645K070384ARGON CONTINUOUS FLUSH DEVICEKRA2007-03-29
224471198255648K053518INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHORNEU2006-01-26
224471293422238K052169IMC SURGICAL DRAPESKKX2005-11-17
224471966480572K032840ATRION MEDICAL QL INFLATION DEVICEKOE2004-03-03
224471417926456K031442PBN GUIDEWIRESDQX2003-08-13
224471401995941K030334T-SCIENTIFIC T-PADQSY2003-04-21
224471622388969K022895ELCAM STOPCOCKS AND MANIFOLDSFMG2002-10-18
224471706962995K022634CO-AXIAL INTRODUCER NEEDLEDYB2002-11-06
224471552104697K021606EN-SNARE ENDOVASCULAR SNARE AND CATHETERMMX2002-05-31
224471983888971K014239MEDSURG EQUIPMENT COVERSMMP2002-02-19
224471932295509K011790MICROCRUISER PLUS INTRODUCER SETDYB2001-09-05
224471146402389K011270AUTOMATED CORE BIOPSY DEVICEFCG2001-06-22
224471103355036K001872I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411FPA2000-09-07
224471967075918K000620PBN FALLOPIAN TUBE CATHETER SYSTEMMDG2000-10-30
224471114573379K000433PBN HYSTERO-SALPINGOGRAPHY CATHETER SETLKF2000-06-16
224471000894191
224471005367102
224471031332893
224471188339793
224471229245111
224471236299763
224471245844778
224471312320483
224471322668271
224471335693230
224471417775402
224471419561419

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB132025-12-15
KNW132022-07-01
FOZ72021-02-08
DQO62023-06-01
LJS52023-11-30
QEW42024-03-28
MMX42021-01-05
DTL41996-12-17
DQX32016-12-08
DTK32015-04-16
FGE32008-01-24
MCW22012-06-01
KKX22005-11-17
FPA22000-09-07
DXC21998-07-09
DRC21998-04-06
DRE21997-03-11
GDJ21978-12-15
MSD12010-11-18
KRA12007-03-29
NEU12006-01-26
KOE12004-03-03
QSY12003-04-21
FMG12002-10-18
MMP12002-02-19
FCG12001-06-22
MDG12000-10-30
LKF12000-06-16
KNY11999-04-23
BSP11999-01-08
FMI11998-04-23
EXF11998-01-30
GAA11998-01-08
MAV11996-04-17
DWZ11995-07-27
IWJ11995-02-24
DWO11992-06-19
KRB11991-09-27
IZI11991-09-16
DXT11991-01-15

PMN#