FDA.reportPublic FDA data

Teleflex LLC (NADC 2)

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30104257783010425778Teleflex LLC (NADC 2)1Y2020-04-2511245 N. Distribution Cove Olive Branch MS US 38654

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1724091584152356K9939668FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETERDSP2000-02-18
1724091955654461K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
1724091809284984K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
1724091244059733K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-09-03
1724091563987254K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
1724091681863125K991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-06-22
1724091728244403K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPB1999-05-18
1724091059631032K982313HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPSFZP1998-08-10
1724091006486615K980987BECTON DICKINSON SYRINGEFMF1998-06-11
1724092023235288K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
1724091160820983K970229ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SETDYB1998-02-13
1724091590769050K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
1724091462899987K963257PERIPHERALLY INSERTED MEDLINE CATHETERLJS1997-03-04
1724091709401650K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
1724091196540242K960479ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETERLDF1996-10-17
1724091442195358K960400DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)FBM1996-03-12
1724091333826208K953746ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SETFPA1996-01-26
1724091953764170K944552PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIPFZP1994-11-07
1724091887369824K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
1724091969280430K931644GERTIE MARX NEEDLEBSP1993-09-22
1724091886116299K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERLJS1994-03-28
1724091387695659K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETDYB1993-04-22
1724091176989150K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
1724091190045940K923653NEEDLELESS INJECTION CANNULALJS1993-05-13
1724091839565881K911260ATRAUMATIC STANDARD SPROTTE NEEDLEBSP1991-10-21
1724091939658092K904021PNEUMOTHORAX KIT, MODIFICATIONJDC1990-10-09
1724091596089108K900263ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ1990-07-24
1724091174626781K895516CAVITY DRAINAGE CATHETERIZATION SET, CS-01600GBX1989-12-27
1724091113684393K895417ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KITLFJ1990-01-03
1724091497490498K884552CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETERCAZ1989-03-14
1724091723632989K884490INTRODUCER SAFETY SYRINGEDQX1989-01-17
1724091896953948K883905ARROW PNEUMOTHORAX KIT, AK-01500JOL1989-01-19
1724091835631175K874105BRACHIAL PLEXUS CATHETER - BP-01200CAZ1987-11-24
1724091731679523K874063ENTERON ABDOMINAL PARACENTESIS TRAYKDD1987-12-04
1724091589060755K874062ENTERON LIVER BIOPSY TRAYKNW1987-12-31
1724092051115926K873943CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERSCAZ1987-10-20
1724091485990110K870572ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KITJOL1987-05-26
1724091992695827K862153ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLEFOZ1986-12-11
1724092037515436K862056[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPDQY1986-08-25
1724091865322735K854137ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & ECDQY1985-12-03
1724091139135852K851251AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200FZP1985-07-02
1724091622566505K843263ARROW-JOHANS ECG ADAPTORDQY1984-09-20
1724091487598729K841548HEMOCLIP LIGATING CLIPS M/LARGEFZP1984-08-14
1724091375132023K841547HEMOCLIP LIGATING CLIPS MED/SMLFZP1984-08-14
1724091199053651K840455EMERGENCY INFUSION DEVICEDYB1984-05-23
1724091793178339K820648ARROW M.I.S. MULTI-LUMEN CATHETERIZADQY1982-04-14
1724091449956153K820009ARROW JUGULAR PUNCTURE KIT 16 GA.DQY1982-01-22
1724091991344321K811627ARROW PERITONEAL LAVAGE CATHERIZATION KGBW1981-08-10
1724091465840924K810962ARROW VESSEL CATHETER. KIT W/20GA INDWELDQY1981-04-29
1724091363114653K810675ARROW RADIAL ARTERY CATHETERIZATION SETDQX1981-03-27
1724091430157419K810324AUTOMATIC HEMOCLIP APPLIER, 527700GDW1981-03-20
1724091338359105K802367ARROW CATHETER CLAMPKGZ1980-10-23
1724091629193148K801912ARROW POSITIVE PLACEMENT CON/EPIDURAL ANCAZ1980-09-16
1724091666476757K780532PERCUTANEOUS SHEATH INTRODUCER KITDYB1978-04-21
1724091261877661K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
1724091707449317K770356ANESTHESIA KIT, EPIDURAL, SINGLE SHOTCAZ1977-03-01
1724091142442377K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.DQY2017-06-23
1724091695352870K162522UltraCath Continuous Nerve block CatheterBSO2017-03-17
1724091144121626K160925VPS Rhythm Device with TipTracker TechnologyLJS2016-12-22
1724091293726322K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetCAZ2016-06-21
1724091972797926K141051VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HUMSD2014-07-07
1724091320850272K123813VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLEOBJ2013-01-18
1724091291055702K123759CG+ ARROW PICC POWERED BY ARROW VPS STYLETLJS2013-01-03
1724091139983152K122854ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCERDYB2013-01-04
1724091621469403K122027ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETERCAZ2012-08-28
1724091224147776K121403CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SETCAZ2012-06-20
1724091570153039K113277ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITSLJS2012-06-21
1724091195054331K112896ARRW EVOLUTIONLJS2012-05-10
1724091025663053K112554TRANSRADIAL ARTERY ACCESS DEVICESDYB2011-11-18
1724091992940762K111900NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETERMSD2011-08-17
1724091411286905K111117CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...MSD2011-06-30
1724091813678552K103658FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERCAZ2012-05-16
1724091188474254K103260VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLEOBJ2011-02-18
1724091463258001K103255VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLETOBJ2011-02-18
1724092037979320K102238ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETERMSD2011-02-01
1724091116819958K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504LJS2010-08-27
1724091654324518K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520DQY2009-12-18
1724091717799316K080684WG-SURGICAL SUTURES WITH NEEDLEGAP2008-06-09
1724091132967132K080604PRESSURE INJFECTABLE PICCLJS2008-06-27
1724091430843485K073451PRESSURE INJECTABLE PICCLJS2008-01-15
1724091434810334K071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENTFMI2007-09-26
1724091486042555K071538ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETERFOZ2007-08-30
1724091078414741K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPESKKX2007-10-10
1724091422739965K071111NON-ABSORBABLE SILK SUTUREGAP2007-07-17
1724091604807195K070903MYLAB40ITX2007-07-02
1724091010463069K061289ARROW PRESSURE INJECTABLE PICCLJS2006-08-24
1724091211937055K060801DEKNA-LOK MODEL BP1000V2LGAM2006-05-17
1724091316572559K042141POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTUREGAM2004-09-28
1724091658455175K041153SHARPSAWAY II LOCKING DISPOSABLE CUPFMI2004-07-12
1724091264906569K040666STEP-TIP CHRONIC HEMODIALYSIS CATHETERMSD2004-05-14
1724091717075154K040260INTEGRAL HEMODIALYSIS CATHETERMSD2004-03-05
1724091036645046K040078CANNON II PLUSMSD2004-02-13
1724091196131243K030937STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PKCAZ2003-04-23
1724091214930702K022989RADLITE TISSUE RETRACTOR SYSTEMFSW2002-11-25
1724091276743352K022895ELCAM STOPCOCKS AND MANIFOLDSFMG2002-10-18
1724091203442976K022662DIATEK CANNON-CATHETER, MODEL CC5500MSD2003-05-09
1724092045508418K021990GALT MEDICAL GUIDEWIREDQX2002-07-18
1724091366581719K021723SHEATH ADAPTER, MODEL SA-09847DYB2002-08-08
1724091933008854K021567STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000CAZ2002-06-19
1724091833277097K021120RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SPDQY2002-05-02
1724091617639035K020430DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)NFK2002-05-09
1724091308165913K011761MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORTDYB2001-10-31
1724091711396919K011084MANDREL GUIDEWIRE ASSEMBLYDQX2001-05-10
1724091832649392K011056ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTDQEW2001-10-24
1724091805672353K010399DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)MSD2001-08-14
1724091053719691K003006TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTIONLJT2000-10-27
1724091810095315K002507TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORTDYB2001-03-21
1724091807182109K001731AVID-NIT LOSS OF RESISTANCE SYRINGEFMF2000-08-29
1724091036606293
1724091128351341
1724091259268009
1724091281010960
1724091294315107
1724091475132091
1724091536219520
1724091610533436
1724091643357346
1724091662687844
1724091677063842
1724091880388041

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LJS112016-12-22
CAZ112016-06-21
DYB102013-01-04
DQY92017-06-23
MSD92014-07-07
FOZ62007-08-30
DQX62002-07-18
FZP51998-08-10
GAM42006-05-17
OBJ32013-01-18
MPB32000-09-14
GAP22008-06-09
KKX22007-10-10
FMI22007-09-26
FMF22000-08-29
BSP21993-09-22
JOL21989-01-19
BSO12017-03-17
ITX12007-07-02
FSW12002-11-25
FMG12002-10-18
NFK12002-05-09
QEW12001-10-24
LJT12000-10-27
DSP12000-02-18
LDF11996-10-17
FBM11996-03-12
FPA11996-01-26
JDC11990-10-09
LFJ11990-01-03
GBX11989-12-27
KNW11987-12-31
KDD11987-12-04
GBW11981-08-10
GDW11981-03-20
KGZ11980-10-23