FDA.reportPublic FDA data

Arrow International C.R. a.s.

Matched from indexed company URL: ARROW INTERNATIONAL INC.

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
30105326123010532612Arrow International, LLC (subsidiary of Teleflex, Incorporated)1N2026-01-0116 Elizabeth Dr Chelmsford MA US 01824
30131622913013162291Arrow International LLC (subsidiary of Teleflex Incorporated)1Y2026-01-013015 Carrington Mill Blvd. Morrisville NC US 27560
30158597093015859709Arrow International, LLC (subsidiary of Teleflex Incorporated)1N2026-01-0135 Innovation Way Wyomissing PA US 19610
10368441036844Arrow International, Inc.1Y2020-04-25312 Commerce Place ASHEBORO NC US 27203
25184332518433Arrow International, Inc. (subsidiary of Teleflex, Inc.)1Y2020-04-252400 Bernville Road Reading PA US 19605

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
381841584152356K9939668FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETERDSP2000-02-18
381851584152356K9939668FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETERDSP2000-02-18
1629891584152356K9939668FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETERDSP2000-02-18
2338321584152356K9939668FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETERDSP2000-02-18
381841955654461K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
381851955654461K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
381881955654461K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
2337801955654461K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
381841809284984K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
381851809284984K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
381881809284984K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
2337801809284984K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
2337801838925400K993191TFX MEDICAL INTRODUCER ASSEMBLYDYB2000-03-24
381841244059733K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-09-03
381841668563411K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXX1999-08-23
381881668563411K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXX1999-08-23
381841563987254K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
381851563987254K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
381881563987254K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
2337801563987254K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
381841681863125K991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAM1999-06-22
381851050651565K990829ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65MCW1999-05-04
2337801050651565K990829ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65MCW1999-05-04
381842063264624K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
1629892063264624K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
381841728244403K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPB1999-05-18
381851728244403K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPB1999-05-18
381881728244403K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPB1999-05-18
2337801728244403K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPB1999-05-18
381841059631032K982313HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPSFZP1998-08-10
381851095373092K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersDSP1998-10-16
1629891095373092K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersDSP1998-10-16
2338321095373092K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersDSP1998-10-16
381841006486615K980987BECTON DICKINSON SYRINGEFMF1998-06-11
381881006486615K980987BECTON DICKINSON SYRINGEFMF1998-06-11
381841697419000K980536EPIDURAL NEEDLEBSP1998-07-31
381841067658730K980210VARIOUS SURGICAL OR PATIENT DRAPESKKX1998-05-15
381881275996537K974083CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKSFMG1998-01-13
381842023235288K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
381852023235288K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
381882023235288K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
2337802023235288K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
381841409046128K970855CLAVE CONNECTORFPA1997-06-24
381841282754616K970513GENERAL PURPOSE TRANDUCER COVERITX1997-06-20
381851160820983K970229ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SETDYB1998-02-13
2337801160820983K970229ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SETDYB1998-02-13
381841746956134K965107MEDLINE ADMISSION KITSFXX1997-03-11
381841590769050K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
381851590769050K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
381881590769050K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
2337801590769050K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
381841462899987K963257PERIPHERALLY INSERTED MEDLINE CATHETERLJS1997-03-04
381851462899987K963257PERIPHERALLY INSERTED MEDLINE CATHETERLJS1997-03-04
381881462899987K963257PERIPHERALLY INSERTED MEDLINE CATHETERLJS1997-03-04
2337801462899987K963257PERIPHERALLY INSERTED MEDLINE CATHETERLJS1997-03-04
381841709401650K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
381851709401650K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
381881709401650K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
2337801709401650K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
381841943072842K962042GLASS SYRINGEFMF1996-10-08
381841196540242K960479ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETERLDF1996-10-17
381851196540242K960479ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETERLDF1996-10-17
1629891196540242K960479ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETERLDF1996-10-17
2337801196540242K960479ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETERLDF1996-10-17
2338321196540242K960479ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETERLDF1996-10-17
381841442195358K960400DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)FBM1996-03-12
381841333826208K953746ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SETFPA1996-01-26
381851333826208K953746ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SETFPA1996-01-26
2337801333826208K953746ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SETFPA1996-01-26
381841890006034K952861ANGIOCATH & INSYTE AUTOGUARD CATHETERSFOZ1995-07-31
381841303976207K951254SAFETYGLIDE NEEDLEFMI1995-10-07
381842046899166K950301ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERSFOZ1995-04-18
381882046899166K950301ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERSFOZ1995-04-18
381841525690021K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
381881525690021K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
381851841655507K945229ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERSDRF1995-08-08
1629891841655507K945229ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERSDRF1995-08-08
2337801841655507K945229ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERSDRF1995-08-08
2338321841655507K945229ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERSDRF1995-08-08
381841953764170K944552PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIPFZP1994-11-07
381841314407258K944355NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLESFMF1994-12-07
381881314407258K944355NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLESFMF1994-12-07
381881597372826K942045INSYTE INTRODUCER CATHETERFOZ1995-01-09
381842032095359K940440DUKAL NON-WOVEN GAUZEEFQ1994-03-09
381841887369824K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
381851887369824K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
381881887369824K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
2337801887369824K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
381841099555211K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
381851099555211K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
381881099555211K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
2337801099555211K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
381841969280430K931644GERTIE MARX NEEDLEBSP1993-09-22
381881969280430K931644GERTIE MARX NEEDLEBSP1993-09-22
381841754980459K931202STERILIZATION WRAP-STERISHEETFRG1993-12-16
381881754980459K931202STERILIZATION WRAP-STERISHEETFRG1993-12-16
381841416549702K930826SUTURE NONABSORBABLE - SILKGAP1994-01-07
381881416549702K930826SUTURE NONABSORBABLE - SILKGAP1994-01-07
381841596490395K930825SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLESGAP1994-01-07
381841886116299K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERLJS1994-03-28
381851886116299K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERLJS1994-03-28
381881886116299K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERLJS1994-03-28
2337801886116299K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERLJS1994-03-28
381841195955124K925126INTERLINK(TM) INJECTION SITEFPA1993-06-18
381881195955124K925126INTERLINK(TM) INJECTION SITEFPA1993-06-18
381841387695659K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETDYB1993-04-22
381851387695659K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETDYB1993-04-22
381881387695659K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETDYB1993-04-22
2337801387695659K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETDYB1993-04-22
381841176989150K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
381851176989150K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
381881176989150K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
2337801176989150K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
2338321176989150K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
381841190045940K923653NEEDLELESS INJECTION CANNULALJS1993-05-13
381851190045940K923653NEEDLELESS INJECTION CANNULALJS1993-05-13
381881190045940K923653NEEDLELESS INJECTION CANNULALJS1993-05-13
2337801190045940K923653NEEDLELESS INJECTION CANNULALJS1993-05-13
381841504510417K923127NEEDLE-PRO CARTRIDGEFMI1993-04-29
381841076496627K914531STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRESDQX1992-02-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAZ702023-02-13
LJS672022-08-22
FOZ422025-03-14
DQY412017-06-23
DQX402024-09-18
DYB402013-01-04
FMI362023-07-25
DSP312025-03-26
MSD302014-07-07
KKX242010-11-09
FMF192008-11-28
DYG181989-09-26
BSP172019-08-21
OBJ142014-07-08
MPB122000-09-14
BSO102017-03-17
DQO102002-05-02
GAP92008-06-09
FPA82006-07-10
DRF81995-08-08
KGZ71980-10-23
JOL61989-01-19
PND52022-09-02
FMG52002-10-18
FZP51998-08-10
LDF51996-10-17
GAM42006-05-17
LJT42000-10-27
FXX41999-08-23
FRG41993-12-16
NGT32017-12-21
NIE32015-07-24
NFK32002-05-09
QEW32001-10-24
JDC31990-10-09
LFJ31990-01-03
GBX31989-12-27
KDD31987-12-04
GBW31981-08-10
DRB22022-08-30

PMN#

CG+ Arrow JACC

2016-09-06

ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX,

ARRW EVOLUTION

2012-05-10

ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)

48 records. Showing 1-40. Next