FDA.reportPublic FDA data

Arrow International C.R. a.s.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30064258763006425876Arrow International C.R. a.s.1N2026-01-01JAMSKA 2359/47 ZDAR NAD SAZAVOU Vysocina CZ 591 01

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
381881955654461K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
381881809284984K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
381881668563411K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXX1999-08-23
381881563987254K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
381881728244403K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPB1999-05-18
381881006486615K980987BECTON DICKINSON SYRINGEFMF1998-06-11
381881275996537K974083CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKSFMG1998-01-13
381882023235288K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
381881590769050K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
381881462899987K963257PERIPHERALLY INSERTED MEDLINE CATHETERLJS1997-03-04
381881709401650K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
381882046899166K950301ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERSFOZ1995-04-18
381881525690021K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
381881314407258K944355NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLESFMF1994-12-07
381881597372826K942045INSYTE INTRODUCER CATHETERFOZ1995-01-09
381881887369824K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
381881099555211K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
381881969280430K931644GERTIE MARX NEEDLEBSP1993-09-22
381881754980459K931202STERILIZATION WRAP-STERISHEETFRG1993-12-16
381881416549702K930826SUTURE NONABSORBABLE - SILKGAP1994-01-07
381881886116299K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERLJS1994-03-28
381881195955124K925126INTERLINK(TM) INJECTION SITEFPA1993-06-18
381881387695659K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETDYB1993-04-22
381881176989150K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
381881190045940K923653NEEDLELESS INJECTION CANNULALJS1993-05-13
381881076496627K914531STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRESDQX1992-02-27
381881839565881K911260ATRAUMATIC STANDARD SPROTTE NEEDLEBSP1991-10-21
381881470880327K903029STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTUREGAR1990-10-25
381881596089108K900263ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ1990-07-24
381881113684393K895417ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KITLFJ1990-01-03
381881301431403K895268ARROW HANDS-OFF THERMO-PACEDQO1989-11-06
381881497490498K884552CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETERCAZ1989-03-14
381881723632989K884490INTRODUCER SAFETY SYRINGEDQX1989-01-17
381881404510994K862801SPUNGUARD PLUS SURGICAL DRAPEKKX1986-08-07
381882037515436K862056[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPDQY1986-08-25
381881403581227K854816EPIDURAL ANESTHESIA NEEDLESBSP1985-12-19
381881077602430K850960NON-ABSORBENT DRAPES & ABSORBENT TOWELSKKX1986-03-15
381881974166988K850199POLY-LINED TOWEL/DRAPE LINEKKX1985-02-21
381881622566505K843263ARROW-JOHANS ECG ADAPTORDQY1984-09-20
381881476118530K833918INFUSION PORT BALLOON THERMODILUTIONDYG1984-01-30
381881132641034K833572HEPARIN-COATED BALLOON THERMODILUTDYG1984-01-30
381881793178339K820648ARROW M.I.S. MULTI-LUMEN CATHETERIZADQY1982-04-14
381881449956153K820009ARROW JUGULAR PUNCTURE KIT 16 GA.DQY1982-01-22
381881465840924K810962ARROW VESSEL CATHETER. KIT W/20GA INDWELDQY1981-04-29
381881363114653K810675ARROW RADIAL ARTERY CATHETERIZATION SETDQX1981-03-27
381881629193148K801912ARROW POSITIVE PLACEMENT CON/EPIDURAL ANCAZ1980-09-16
381881148411274K801343B-D FILTER NEEDLEFPB1980-06-20
381881657731283K800123DEXTEX II STERILIZATION WRAPFRG1980-02-13
381881506978647K7821683-WAY STOPCOCKFMG1979-02-22
381881966885329K782095STOPCOCKS, MANIFOLDSDTL1979-01-23
381881461650635K781978PUNCTURE KIT, DISPOSALBE VEINFMF1978-12-12
381881872904181K781846ADAPTER, CATHETER SHEATHKGZ1978-12-12
381881666476757K780532PERCUTANEOUS SHEATH INTRODUCER KITDYB1978-04-21
381881261877661K770977CARDIOVASCULAR SPRING GUIDESDQX1977-06-14
381881142950080K770462PUNCTURE KIT, INTERNAL JUGULARDQO1977-03-14
381881707449317K770356ANESTHESIA KIT, EPIDURAL, SINGLE SHOTCAZ1977-03-01
381881437641726K222341Arrow 0.2 Micron Flat Filter, GVSCAZ2023-02-13
381881142442377K171146Arrow 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
381881695352870K162522UltraCath Continuous Nerve block CatheterBSO2017-03-17
381881029417387K161170BD Eclipse Hypodermic NeedleFMI2016-05-27
381881494904456K161075Arrow Epidural Catheter KitCAZ2016-10-04
381881293726322K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetCAZ2016-06-21
381881386752970K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleBSP2015-01-14
381881134809689K140110FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SETBSO2015-03-27
381881009804227K133280TERUMO SURFLO I.V. CATHETERFOZ2014-06-12
381881563622854K130876CG+ ARROW PICC POWERED BY ARROW VPS STYLETLJS2013-04-26
381881139983152K122854ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCERDYB2013-01-04
381881621469403K122027ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETERCAZ2012-08-28
381881502320830K121462EZ-BLOCKERCBI2012-09-28
381881224147776K121403CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SETCAZ2012-06-20
381881570153039K113277ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITSLJS2012-06-21
381881195054331K112896ARRW EVOLUTIONLJS2012-05-10
381881813678552K103658FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERCAZ2012-05-16
381881547649833K101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)KKX2010-10-04
381882022443879K101593EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLFYA2010-09-03
381881654324518K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520DQY2009-12-18
381881928522072K082674SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGEFMF2008-11-28
381881688328878K082297BUSSE SURGICAL DRAPEKKX2008-12-09
381881717799316K080684WG-SURGICAL SUTURES WITH NEEDLEGAP2008-06-09
381881132967132K080604PRESSURE INJFECTABLE PICCLJS2008-06-27
381881214019934K080144MANDREL GUIDEWIRES OR M-WIRESDQX2008-02-26
381882009092082K072247STERICAN HYPODERMIC NEEDLESFMI2007-11-08
381881486042555K071538ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETERFOZ2007-08-30
381881078414741K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPESKKX2007-10-10
381881215839050K071459B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGESFMF2007-08-16
381881422739965K071111NON-ABSORBABLE SILK SUTUREGAP2007-07-17
381881359404720K070150VASCUPUNCTURE PICC GUIDEWIREDQX2007-02-15
381881034549804K063280INJEKT SYRINGEFMF2006-11-17
381881010463069K061289ARROW PRESSURE INJECTABLE PICCLJS2006-08-24
381881444521436K042126PICCLJS2004-08-27
381881658455175K041153SHARPSAWAY II LOCKING DISPOSABLE CUPFMI2004-07-12
381882029934445K040965PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLESBSP2004-09-07
381881196131243K030937STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PKCAZ2003-04-23
381881276743352K022895ELCAM STOPCOCKS AND MANIFOLDSFMG2002-10-18
381881933008854K021567STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000CAZ2002-06-19
381881633931238K021475BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETFMI2002-07-19
381881833277097K021120RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SPDQY2002-05-02
381881308165913K011761MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORTDYB2001-10-31
381881711396919K011084MANDREL GUIDEWIRE ASSEMBLYDQX2001-05-10
381881637041847K010188BD ECLIPSE HYPODERMIC NEEDLEFMI2001-03-01
381881053719691K003006TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTIONLJT2000-10-27
381881810095315K002507TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORTDYB2001-03-21
381881807182109K001731AVID-NIT LOSS OF RESISTANCE SYRINGEFMF2000-08-29
381882017574835K00158719 GA PLASTIC REINFORCED EPIDURAL CATHETERCAZ2000-07-12
381882069448297K000313TEARAWAY INTRODUCER SHEATHDYB2000-06-16
381881662687844
381881032664370
381881255689570
381881267235820
381881281010960
381881319697587
381881394907369
381881581875932
381881714727242
381881715868056
381881783893385
381881886373173
381881903142083
381881977916711
381882009737339

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAZ122023-02-13
LJS92013-04-26
DQX92008-02-26
DQY82017-06-23
FOZ82014-06-12
DYB72013-01-04
KKX72010-10-04
FMF72008-11-28
FMI52016-05-27
BSP52015-01-14
GAP32008-06-09
FMG32002-10-18
MPB32000-09-14
BSO22017-03-17
FRG21993-12-16
DQO21989-11-06
DYG21984-01-30
CBI12012-09-28
FYA12010-09-03
LJT12000-10-27
FXX11999-08-23
GAQ11995-01-09
FPA11993-06-18
GAR11990-10-25
LFJ11990-01-03
FPB11980-06-20
DTL11979-01-23
KGZ11978-12-12