Arrow International, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1036844	1036844	Arrow International, Inc.	1	Y	2020-04-25	312 Commerce Place ASHEBORO NC US 27203

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
38184	1584152356	K993966	8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER	DSP	2000-02-18
38184	1955654461	K993933	14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO	MPB	2000-09-14
38184	1809284984	K993691	ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER	FOZ	2000-03-08
38184	1244059733	K992088	BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE	GAM	1999-09-03
38184	1668563411	K991559	MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD	FXX	1999-08-23
38184	1563987254	K991431	14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT	MPB	1999-05-26
38184	1681863125	K991191	BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE	GAM	1999-06-22
38184	2063264624	K990236	MODIFICATION OF JELCO,JELCO-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT	FOZ	1999-08-20
38184	1728244403	K984022	PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT	MPB	1999-05-18
38184	1059631032	K982313	HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS	FZP	1998-08-10
38184	1006486615	K980987	BECTON DICKINSON SYRINGE	FMF	1998-06-11
38184	1697419000	K980536	EPIDURAL NEEDLE	BSP	1998-07-31
38184	1067658730	K980210	VARIOUS SURGICAL OR PATIENT DRAPES	KKX	1998-05-15
38184	2023235288	K970864	ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS	FOZ	1997-10-17
38184	1409046128	K970855	CLAVE CONNECTOR	FPA	1997-06-24
38184	1282754616	K970513	GENERAL PURPOSE TRANDUCER COVER	ITX	1997-06-20
38184	1746956134	K965107	MEDLINE ADMISSION KITS	FXX	1997-03-11
38184	1590769050	K964142	MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS	KKX	1997-02-25
38184	1462899987	K963257	PERIPHERALLY INSERTED MEDLINE CATHETER	LJS	1997-03-04
38184	1709401650	K962577	ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER	FOZ	1997-08-21
38184	1943072842	K962042	GLASS SYRINGE	FMF	1996-10-08
38184	1196540242	K960479	ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER	LDF	1996-10-17
38184	1442195358	K960400	DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)	FBM	1996-03-12
38184	1333826208	K953746	ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET	FPA	1996-01-26
38184	1890006034	K952861	ANGIOCATH & INSYTE AUTOGUARD CATHETERS	FOZ	1995-07-31
38184	1303976207	K951254	SAFETYGLIDE NEEDLE	FMI	1995-10-07
38184	2046899166	K950301	ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS	FOZ	1995-04-18
38184	1525690021	K946173	STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK	GAQ	1995-01-09
38184	1953764170	K944552	PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP	FZP	1994-11-07
38184	1314407258	K944355	NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES	FMF	1994-12-07
38184	2032095359	K940440	DUKAL NON-WOVEN GAUZE	EFQ	1994-03-09
38184	1887369824	K940079	ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903	DYB	1994-11-30
38184	1099555211	K935170	CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS	DQX	1994-03-31
38184	1969280430	K931644	GERTIE MARX NEEDLE	BSP	1993-09-22
38184	1754980459	K931202	STERILIZATION WRAP-STERISHEET	FRG	1993-12-16
38184	1416549702	K930826	SUTURE NONABSORBABLE - SILK	GAP	1994-01-07
38184	1596490395	K930825	SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES	GAP	1994-01-07
38184	1886116299	K930129	ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER	LJS	1994-03-28
38184	1195955124	K925126	INTERLINK(TM) INJECTION SITE	FPA	1993-06-18
38184	1387695659	K924607	ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET	DYB	1993-04-22
38184	1176989150	K924385	NEW HYDROPHILIC COATING FOR WIRE GUIDES	DQX	1993-08-15
38184	1190045940	K923653	NEEDLELESS INJECTION CANNULA	LJS	1993-05-13
38184	1504510417	K923127	NEEDLE-PRO CARTRIDGE	FMI	1993-04-29
38184	1076496627	K914531	STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES	DQX	1992-02-27
38184	1839565881	K911260	ATRAUMATIC STANDARD SPROTTE NEEDLE	BSP	1991-10-21
38184	1695365307	K910182	3M BRAND EAR LOOP FACE MASK, 2000F	FXX	1991-03-04
38184	1939658092	K904021	PNEUMOTHORAX KIT, MODIFICATION	JDC	1990-10-09
38184	1470880327	K903029	STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE	GAR	1990-10-25
38184	1596089108	K900263	ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER	FOZ	1990-07-24
38184	1174626781	K895516	CAVITY DRAINAGE CATHETERIZATION SET, CS-01600	GBX	1989-12-27
38184	1113684393	K895417	ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT	LFJ	1990-01-03
38184	1497490498	K884552	CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER	CAZ	1989-03-14
38184	1723632989	K884490	INTRODUCER SAFETY SYRINGE	DQX	1989-01-17
38184	1896953948	K883905	ARROW PNEUMOTHORAX KIT, AK-01500	JOL	1989-01-19
38184	1644821899	K882724	MICROTEK PROBE DRAPE	KKX	1988-08-03
38184	1835631175	K874105	BRACHIAL PLEXUS CATHETER - BP-01200	CAZ	1987-11-24
38184	1731679523	K874063	ENTERON ABDOMINAL PARACENTESIS TRAY	KDD	1987-12-04
38184	1589060755	K874062	ENTERON LIVER BIOPSY TRAY	KNW	1987-12-31
38184	2051115926	K873943	CONTINUOUS EPIDURAL ANESTH. KITS W/NYLON CATHETERS	CAZ	1987-10-20
38184	1485990110	K870572	ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT	JOL	1987-05-26
38184	1404510994	K862801	SPUNGUARD PLUS SURGICAL DRAPE	KKX	1986-08-07
38184	2037515436	K862056	[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP	DQY	1986-08-25
38184	1716902951	K861558	APLICARE SKIN PROTECTANT SWABSTICK	NEC	1986-06-04
38184	1403581227	K854816	EPIDURAL ANESTHESIA NEEDLES	BSP	1985-12-19
38184	1865322735	K854137	ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC	DQY	1985-12-03
38184	1139135852	K851251	AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200	FZP	1985-07-02
38184	1077602430	K850960	NON-ABSORBENT DRAPES & ABSORBENT TOWELS	KKX	1986-03-15
38184	1974166988	K850199	POLY-LINED TOWEL/DRAPE LINE	KKX	1985-02-21
38184	1756335081	K843414	TOP HYPODERMIC SYRINGE PISTON	FMF	1984-09-07
38184	1622566505	K843263	ARROW-JOHANS ECG ADAPTOR	DQY	1984-09-20
38184	1487598729	K841548	HEMOCLIP LIGATING CLIPS M/LARGE	FZP	1984-08-14
38184	1375132023	K841547	HEMOCLIP LIGATING CLIPS MED/SML	FZP	1984-08-14
38184	1199053651	K840455	EMERGENCY INFUSION DEVICE	DYB	1984-05-23
38184	1055555296	K840336	RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI	DQY	1984-02-17
38184	1424844577	K833184	APLICARE THREE ALCOHOL SWABSTICKS	LKB	1983-10-27
38184	1793178339	K820648	ARROW M.I.S. MULTI-LUMEN CATHETERIZA	DQY	1982-04-14
38184	1449956153	K820009	ARROW JUGULAR PUNCTURE KIT 16 GA.	DQY	1982-01-22
38184	1991344321	K811627	ARROW PERITONEAL LAVAGE CATHERIZATION K	GBW	1981-08-10
38184	1465840924	K810962	ARROW VESSEL CATHETER. KIT W/20GA INDWEL	DQY	1981-04-29
38184	1363114653	K810675	ARROW RADIAL ARTERY CATHETERIZATION SET	DQX	1981-03-27
38184	1430157419	K810324	AUTOMATIC HEMOCLIP APPLIER, 527700	GDW	1981-03-20
38184	1338359105	K802367	ARROW CATHETER CLAMP	KGZ	1980-10-23
38184	2016722402	K802146	AQUASONIC 100 ULTRASOUND TRANS. GEL,	IYO	1980-10-10
38184	1629193148	K801912	ARROW POSITIVE PLACEMENT CON/EPIDURAL AN	CAZ	1980-09-16
38184	1148411274	K801343	B-D FILTER NEEDLE	FPB	1980-06-20
38184	1657731283	K800123	DEXTEX II STERILIZATION WRAP	FRG	1980-02-13
38184	1506978647	K782168	3-WAY STOPCOCK	FMG	1979-02-22
38184	1966885329	K782095	STOPCOCKS, MANIFOLDS	DTL	1979-01-23
38184	1872904181	K781846	ADAPTER, CATHETER SHEATH	KGZ	1978-12-12
38184	1666476757	K780532	PERCUTANEOUS SHEATH INTRODUCER KIT	DYB	1978-04-21
38184	1329956250	K771052	BLOOD COLLECTION TUBE, LAVENDER	GIM	1977-06-27
38184	1261877661	K770977	CARDIOVASCULAR SPRING GUIDES	DQX	1977-06-14
38184	1142950080	K770462	PUNCTURE KIT, INTERNAL JUGULAR	DQO	1977-03-14
38184	1707449317	K770356	ANESTHESIA KIT, EPIDURAL, SINGLE SHOT	CAZ	1977-03-01
38184	1142442377	K171146	Arrow 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.	DQY	2017-06-23
38184	2044519509	K171109	Praxiject 0.9% NaCl	NGT	2017-12-21
38184	1281848593	K163513	Arrow Endurance Extended Dwell Peripheral Catheter System	FOZ	2017-02-24
38184	1695352870	K162522	UltraCath Continuous Nerve block Catheter	BSO	2017-03-17
38184	1634958745	K161765	CG+ Arrow JACC	LJS	2016-09-06
38184	1176697728	K161313	ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology	PND	2016-08-24
38184	1494904456	K161075	Arrow Epidural Catheter Kit	CAZ	2016-10-04
38184	1144121626	K160925	VPS Rhythm Device with TipTracker Technology	LJS	2016-12-22
38184	1293726322	K153652	ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set	CAZ	2016-06-21
38184	1384043298	K153487	CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS	LJS	2016-02-04
38184	1801415456	K153423	CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC	LJS	2016-01-28
38184	1500259181	K151513	Arrow Endurance Extended Dwell Peripheral Catheter System	FOZ	2015-07-08
38184	1246178586	K143102	Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions	NIE	2015-07-24
38184	1386752970	K142553	UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle	BSP	2015-01-14
38184	1362837169	K141311	0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE	NGT	2014-07-25
38184	1262505009	K141126	UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE	BSP	2014-10-31
38184	1972797926	K141051	VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU	MSD	2014-07-07
38184	1869929404	K140485	MANDREL GUIDEWIRE	DQX	2014-03-27
38184	1134809689	K140110	FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET	BSO	2015-03-27
38184	1009804227	K133280	TERUMO SURFLO I.V. CATHETER	FOZ	2014-06-12
38184	1536314249	K132133	CG+ ARROW JACC POWERED BY ARROW VPS STYLET	OBJ	2013-09-26
38184	1563622854	K130876	CG+ ARROW PICC POWERED BY ARROW VPS STYLET	LJS	2013-04-26
38184	1936065907	K130192	NEXTSTEP RETROGRADE	MSD	2013-05-10
38184	1320850272	K123813	VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE	OBJ	2013-01-18
38184	1291055702	K123759	CG+ ARROW PICC POWERED BY ARROW VPS STYLET	LJS	2013-01-03
38184	1139983152	K122854	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	DYB	2013-01-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LJS	18	2016-12-22
KKX	13	2010-11-09
FOZ	12	2017-02-24
CAZ	12	2016-10-04
DQX	11	2014-03-27
DYB	11	2013-01-04
DQY	10	2017-06-23
MSD	10	2014-07-07
FMI	9	2007-11-08
BSP	7	2015-01-14
FMF	6	2008-11-28
FZP	5	1998-08-10
GAP	4	2008-06-09
GAM	4	2006-05-17
FPA	4	2004-06-04
NGT	3	2017-12-21
OBJ	3	2013-09-26
MPB	3	2000-09-14
FXX	3	1999-08-23
BSO	2	2017-03-17
NEW	2	2012-05-23
ITX	2	2007-07-02
FMG	2	2002-10-18
FRG	2	1993-12-16
JOL	2	1989-01-19
KGZ	2	1980-10-23
PND	1	2016-08-24
NIE	1	2015-07-24
FYA	1	2010-09-03
FSW	1	2002-11-25
NFK	1	2002-05-09
SEL	1	2001-10-26
QEW	1	2001-10-24
LJT	1	2000-10-27
DSP	1	2000-02-18
LDF	1	1996-10-17
FBM	1	1996-03-12
GAQ	1	1995-01-09
EFQ	1	1994-03-09
GAR	1	1990-10-25

PMN#

UltraFlex IAB
2019-06-28
Arrow International, Inc.
Fiberoptix IAB
2019-06-13
Arrow International, Inc.
AC3 Series IABP System
2017-03-31
ARROW INTERNATIONAL, INC.
VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU
2014-07-07
ARROW INTERNATIONAL, INC.
NEXTSTEP RETROGRADE
2013-05-10
ARROW INTERNATIONAL, INC.
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
2013-04-26
ARROW INTERNATIONAL, INC.
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
2012-12-21
ARROW INTERNATIONAL, INC.
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
2012-08-28
ARROW INTERNATIONAL, INC.
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
2012-06-21
ARROW INTERNATIONAL, INC.
PRESSURE INJFECTABLE PICC
2008-06-27
ARROW INTERNATIONAL, INC.
PRESSURE INJECTABLE PICC
2008-01-15
ARROW INTERNATIONAL, INC.
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
2007-08-30
ARROW INTERNATIONAL, INC.
ARROW PRESSURE INJECTABLE PICC
2006-08-24
ARROW INTERNATIONAL, INC.
STEP-TIP CHRONIC HEMODIALYSIS CATHETER
2004-05-14
ARROW INTERNATIONAL, INC.
CANNON II PLUS
2004-02-13
ARROW INTERNATIONAL, INC.
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
2003-04-23
ARROW INTERNATIONAL, INC.
Blood And Plasma Warming Devices
1994-07-14
Arrow International, Inc.