Arrow Intl., Inc.
Medical device manufacturer in Reading, PA.
110510(k) clearances
0PMA approvals
0recalls
Device types
- DSP System, Balloon, Intra-Aortic And Control 15
- CAZ Anesthesia Conduction Kit 11
- DQY Catheter, Percutaneous 11
- DYB Introducer, Catheter 9
- LJT Port & Catheter, Implanted, Subcutaneous… 8
- FOZ Catheter, Intravascular, Therapeutic… 6
- DQX Wire, Guide, Catheter 6
- LJS Catheter, Intravascular, Therapeutic… 6
- FMI Needle, Hypodermic, Single Lumen 4
- MPB Catheter, Hemodialysis, Non-Implanted 3
- DRF Catheter, Electrode Recording, Or Probe… 3
- JOL Catheter And Tip, Suction 2
- MCW Catheter, Peripheral, Atherectomy 2
- KGZ Accessories, Catheter 2
- DQO Catheter, Intravascular, Diagnostic 2
- GBW Catheter, Peritoneal 1
- FMF Syringe, Piston 1
- DXT Injector And Syringe, Angiographic 1
- DYG Catheter, Flow Directed 1
- KKX Drape, Surgical, Antimicrobial 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model:…LJS · Traditional | 08/27/2010SE |
| K093050 | Arrow Seldinger Arterial Catherization Devices, Models Ex Sac 00520DQY · Special | 12/18/2009SE |
| K071491 | Arrow International, Inc., Surgical DrapesKKX · Traditional | 10/10/2007SE |
| K071998 | Arrow Echogenic Introducer Needle ComponentFMI · Special | 09/26/2007SE |
| K071111 | Non-Absorbable Silk SutureGAP · Traditional | 07/17/2007SE |
| K060309 | Autocat Intra-Aortic Balloon Pump SeriesDSP · Special | 04/06/2006SE |
| K042126 | PiccLJS · Special | 08/27/2004SESU |
| K041153 | Sharpsaway II Locking Disposable CupFMI · Traditional | 07/12/2004SE |
| K040801 | Intra-Aortic Balloon (Iab)DSP · Special | 05/06/2004SE |
| K040802 | Hemosonic 200HEMODYNAMIC MonitorDPN · Special | 04/28/2004SE |
| K040100 | Arrow Echogenic Introducer NeedleDQX · Traditional | 03/01/2004SE |
| K031153 | Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065DPW · Traditional | 11/25/2003SE |
| K032962 | Ac 3 Lumen Central Venous Access Kit with Arrowg+Ard Antimicrobial SurfaceFOZ · Special | 10/29/2003SE |
| K022662 | Diatek Cannon-Catheter, Model CC5500MSD · Traditional | 05/09/2003SESK |
| K021723 | Sheath Adapter, Model SA-09847DYB · Traditional | 08/08/2002SE |
| K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000CAZ · Traditional | 06/19/2002SE |
| K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement…DSP · Special | 06/06/2002SE |
| K021120 | Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SPDQY · Special | 05/02/2002SE |
| K011761 | Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral…DYB · Traditional | 10/31/2001SE |
| K011056 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTDQEW · Traditional | 10/24/2001SE |
| K002256 | Arrow Acat 2 Intra-Aortic Balloon PumpDSP · Traditional | 05/03/2001SE |
| K002507 | Two-Lumen Central Venous Access Kit with Hemostasis Valve/Side PortDYB · Traditional | 03/21/2001SE |
| K010330 | Arrow Rediguard, 9FR. 50CC, Intra-Aortic Balloon Vatheter, IAB-R950-UDSP · Special | 03/02/2001SE |
| K003006 | Two-Lumen Picc with Blue Flextip Catheter and Integral Needle ProtectionLJT · Traditional | 10/27/2000SE |
| K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue…MPB · Traditional | 09/14/2000SE |
| K001587 | 19 Ga Plastic Reinforced Epidural CatheterCAZ · Special | 07/12/2000SE |
| K000729 | Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC UniversalDSP · Special | 05/19/2000SE |
| K993691 | Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterFOZ · Traditional | 03/08/2000SE |
| K993966 | 8FR. Narrowflex Universal Intra-Aortic Balloon CatheterDSP · Special | 02/18/2000SE |
| K991431 | 14 Fr. Hemodialysis Two-Lumen Catheterization KitMPB · Special | 05/26/1999SE |
| K984022 | Pediatric Two-Lumen Hemodialysis Catherization KitMPB · Traditional | 05/18/1999SE |
| K990829 | Arrow-Trerotola Percutaneous Thrombolytic Device or PTD, Models PT-45509 (Catheter Kit…MCW · Special | 05/04/1999SE |
| K982141 | Arrow 5FX60CM Balloon Embolectomy Catheter, Model # EM-56025DXE · Traditional | 08/31/1998SE |
| K981782 | Low Profile Port Attachable Catheter with Blue Flex Tip / 8FR. Inroducer Kit Implantable…DYB · Traditional | 08/12/1998SE |
| K970689 | IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-UDSP · Traditional | 06/04/1998SE |
| K970229 | Arrow Transseptal Super Arrow-Flex Percutaneous SetDYB · Traditional | 02/13/1998SE |
| K965209 | Acat 1 (Arrow Cardiac Assist Technology 1)DSP · Traditional | 01/23/1998SE |
| K970864 | Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersFOZ · Traditional | 10/17/1997SE |
| K963865 | 8 Fr. -30CC Narrowflex Sheathless Intra-Aortic Balloon Catheter, Product Number IAB-04830SDSP · Traditional | 09/16/1997SE |
| K962577 | Arrowgard Blue Quad-Lumen Central Venous CatheterFOZ · Traditional | 08/21/1997SE |
| K970080 | Arrow-Trerotola PTD CatheterMCW · Traditional | 07/25/1997SE |
| K963920 | 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,DSP · Traditional | 06/17/1997SE |
| K963257 | Peripherally Inserted Medline CatheterLJS · Traditional | 03/04/1997SE |
| K963104 | 9.5 Fr.- Flexi-Cath Intra-Aortic and Control SystemDSP · Traditional | 02/04/1997SE |
| K963684 | A2 Port, Dual Lumen System with Detached Catheter, Catalog # AP-01518 (Modified)LJT · Traditional | 10/24/1996SE |
| K960479 | Arrow Bipolar Pacing/Balloon Wedge Pressure CatheterLDF · Traditional | 10/17/1996SE |
| K961652 | Low Profile Plastic Port Detached Catheter System Catalog #1017LJT · Traditional | 07/19/1996SE |
| K961615 | Low Profile Titanium Port Detached Catheter System Catalog #1037LJT · Traditional | 07/19/1996SE |
| K961583 | A Port Detached Catheter System Catalog #1002LJT · Traditional | 07/18/1996SE |
| K961358 | Arrow Sheathless Intra-Aortic Balloon CatheterDSP · Traditional | 07/02/1996SE |
| K961088 | Non-Coring NeedleFMI · Traditional | 07/02/1996SE |
| K960713 | 8 FR.-40CC Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number…DSP · Traditional | 05/15/1996SE |
| K960572 | Therex Low Profile B Port 1.0MM I.D./1.8MM O.D. Detached CatheterLJT · Traditional | 04/26/1996SE |
| K955819 | A2 Detached Dual Port SystemLJT · Traditional | 03/21/1996SE |
| K953746 | Arrow High Flow Fluid Adminsitration Set W/Blood Filter & Extension SetFPA · Traditional | 01/26/1996SE |
| K953651 | Diagnostic Electrophysiology Catheter SystemDRF · Traditional | 11/30/1995SE |
| K953073 | Low Profile Titanium Model Catalog #1003LJT · Traditional | 09/19/1995SE |
| K945229 | Arrow Multipolar Intracardiac Electrode CathetersDRF · Traditional | 08/08/1995SE |
| K945230 | Arrow Kink Resistant Flexi-Cath Intra-Aortic BalloonDSP · Traditional | 05/09/1995SE |
| K940079 | Arrow Percutaneous Sheath Introducer Kit AK-07903DYB · Traditional | 11/30/1994SE |
| K930129 | Arrow Picc-Peripherally Inserted Central CatheterLJS · Traditional | 03/28/1994SEKD |
| K933033 | Guiding Catheter Hemostasis Valve CapDQY · Traditional | 09/10/1993SE |
| K924558 | Arrow Blood Containment DeviceDQX · Traditional | 08/19/1993SE |
| K924385 | New Hydrophilic Coating for Wire GuidesDQX · Traditional | 08/15/1993SE |
| K923653 | Needleless Injection CannulaLJS · Traditional | 05/13/1993SE |
| K924607 | Arrow Fischell Kink Resist Percut Sheath Intro SetDYB · Traditional | 04/22/1993SE |
| K924338 | Arrow-Fischell Extended Vascular Access NeedleDRC · Traditional | 03/18/1993SE |
| K911065 | Arrow Quadpolar Mapping/Pacing CatheterDRF · Traditional | 06/18/1992SE |
| K914531 | Stainless Steel Gen Pur Interventional Guide WiresDQX · Traditional | 02/27/1992SE |
| K904404 | Multi-Lumen Central Venous Catheter SetDQY · Traditional | 02/15/1991SE |
| K905229 | Laparoscopic Cholangiography Catheterization SetsFGE · Traditional | 01/18/1991SE |
| K904021 | Pneumothorax Kit, ModificationJDC · Traditional | 10/09/1990SE |
| K900263 | Antimicrobial Multi-Lumen Central Venous CatheterFOZ · Traditional | 07/24/1990SESK |
| K895417 | Arrow Large-Bore Dual Lumen Hemodialysis KitLFJ · Traditional | 01/03/1990SE |
| K895516 | Cavity Drainage Catheterization Set, CS-01600GBX · Traditional | 12/27/1989SE |
| K895268 | Arrow Hands-Off Thermo-PaceDQO · Traditional | 11/06/1989SE |
| K892640 | Pneumothorax Kit, MotificationJDL · Traditional | 10/11/1989SE |
| K892530 | Catheters for Balloon Occlusion Femoral AngiographDYG · Traditional | 09/26/1989SE |
| K891281 | Interpleural Anesthesia Kit W/Polyurethane Cath.CAZ · Traditional | 07/14/1989SE |
| K884552 | Continuous Epidural Anesthesia Kit W/Poly CatheterCAZ · Traditional | 03/14/1989SE |
| K883905 | Arrow Pneumothorax Kit, AK-01500JOL · Traditional | 01/19/1989SESD |
| K884490 | Introducer Safety SyringeDQX · Traditional | 01/17/1989SE |
| K880310 | Angio Drape Pack ACP-010FMDXT · Traditional | 04/22/1988SE |
| K874105 | Brachial Plexus Catheter - BP-01200CAZ · Traditional | 11/24/1987SE |
| K873943 | Continuous Epidural Anesth. Kits W/Nylon CathetersCAZ · Traditional | 10/20/1987SE |
| K870572 | Arrow-Clarke(Tm) Pleura-Seal(Tm) Thoracentesis KitJOL · Traditional | 05/26/1987SE |
| K862153 | Arrow 18GA Two-Lumen Intravenous CATH/23GA NeedleFOZ · Traditional | 12/11/1986SE |
| K862056 | [Central Venous][Multi-Lumen] Catheter W/Flex TipDQY · Traditional | 08/25/1986SE |
| K854137 | Arrow Brachial Central Venous Cath-Kit W/16GA & EcDQY · Traditional | 12/03/1985SE |
| K844080 | Arrow-Geiss Percutaneous TPN KitLJS · Traditional | 04/17/1985SE |
| K843263 | Arrow-Johans ECG AdaptorDQY · Traditional | 09/20/1984SE |
| K840455 | Emergency Infusion DeviceDYB · Traditional | 05/23/1984SE |
| K840336 | Radiopaque 7 FRX 12-POLYURETHANE MultiDQY · Traditional | 02/17/1984SE |
| K820648 | Arrow M.I.S. Multi-Lumen CatheterizaDQY · Traditional | 04/14/1982SE |
| K820009 | Arrow Jugular Puncture Kit 16 Ga.DQY · Traditional | 01/22/1982SE |
| K811627 | Arrow Peritoneal Lavage Catherization KGBW · Traditional | 08/10/1981SE |
| K810979 | Arrow Needle-Catheter Jejunostomy KitKNT · Traditional | 06/02/1981SE |
| K810962 | Arrow Vessel Catheter. Kit W/20GA IndwelDQY · Traditional | 04/29/1981SE |
| K810675 | Arrow Radial Artery Catheterization SetDQX · Traditional | 03/27/1981SE |
| K802367 | Arrow Catheter ClampKGZ · Traditional | 10/23/1980SE |
| K801912 | Arrow Positive Placement Con/Epidural anCAZ · Traditional | 09/16/1980SE |
| K781469 | Positive Placement Anethesia KitCAZ · Traditional | 01/26/1979SE |
| K781978 | Puncture Kit, Disposalbe VeinFMF · Traditional | 12/12/1978SE |
| K781846 | Adapter, Catheter SheathKGZ · Traditional | 12/12/1978SE |
| K780532 | Percutaneous Sheath Introducer KitDYB · Traditional | 04/21/1978SE |
| K770461 | Anesthesia Kit, Epidural Block, Continu.CAZ · Traditional | 03/16/1977SE |
| K770462 | Puncture Kit, Internal JugularDQO · Traditional | 03/14/1977SE |
| K770356 | Anesthesia Kit, Epidural, Single ShotCAZ · Traditional | 03/01/1977SE |
| K761098 | Filter DevicesFMI · Traditional | 01/28/1977SE |
| K761162 | Brachial Plexus Block Anesthesia KitCAZ · Traditional | 12/09/1976SE |