Arrow Intl., Inc.
Also registered as Arrow Int'L.
United StatesFDA applicant, unverified
- Devices
- 111
What Arrow Intl., Inc. makes
Arrow International, Inc. manufactures a range of intravascular and interventional devices, including brachytherapy catheters, peripherally inserted central catheters (PICCs), hemodynamic monitoring systems like the Hemosonic 200, and intra-aortic balloon catheters with various lumen configurations. The portfolio also covers needleless injection cannulas, echogenic introducer needles, guide wires, anesthesia kits with polyurethane catheters, and non-coring needles for medical procedures.
Arrow’s devices are classified under FDA categories Class I, Class II, and Class III, with many listed via the 510(k) pathway. The company’s products are regulated under U.S. medical device laws and appear in the FDA’s 510(k) clearance registry. Arrow International, Inc. is headquartered in the United States.
AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
Peripherally Inserted Medline Catheter Ref K963257
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow Echogenic Introducer Needle Ref K040100
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Arrowg +ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter Ref K993691 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow Peritoneal Lavage Catherization K Ref K811627 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IContinuous Epidural Anesthesia Kit W/Poly Catheter Ref K884552 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINon-Absorbable Silk Suture Ref K071111
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPercutaneous Sheath Introducer Kit Ref K780532 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IITwo-Lumen Picc With Blue Flextip Catheter And Integral Needle Protection Ref K003006 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIIntra-Aortic Balloon (Iab) Ref K040801
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow Catheter Clamp Ref K802367
Active Regimes: 510(k) Registry: 510(k) ClassClass:IArrow Quadpolar Mapping/Pacing Catheter Ref K911065
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow-Geiss Percutaneous Tpn Kit Ref K844080
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAutocat Intra-Aortic Balloon Pump Series Ref K060309 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow Needle-Catheter Jejunostomy Kit Ref K810979
Active Regimes: 510(k) Registry: 510(k) ClassClass:II8 Fr. -30cc Narrowflex Sheathless Intra-Aortic Balloon Catheter, Product Number Iab-04830S Ref K963865
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow M.I.S. Multi-Lumen Catheteriza Ref K820648
Active Regimes: 510(k) Registry: 510(k) ClassClass:IICavity Drainage Catheterization Set, Cs-01600 Ref K895516
Active Regimes: 510(k) Registry: 510(k) ClassClass:IArrow Pneumothorax Kit, Ak-01500 Ref K883905
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPneumothorax Kit, Motification Ref K892640
Active Regimes: 510(k) Registry: 510(k) ClassClass:III- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
A Port Detached Catheter System Catalog #1002 Ref K961583
Active Regimes: 510(k) Registry: 510(k) ClassClass:IINew Hydrophilic Coating For Wire Guides Ref K924385
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIPicc Ref K042126 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow Hands-Off Thermo-Pace Ref K895268
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAdapter, Catheter Sheath Ref K781846
Active Regimes: 510(k) Registry: 510(k) ClassClass:I- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Arrow-Johans Ecg Adaptor Ref K843263
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAntimicrobial Multi-Lumen Central Venous Catheter Ref K900263 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Puncture Kit, Disposalbe Vein Ref K781978 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIAnesthesia Kit, Epidural, Single Shot Ref K770356
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Diatek Cannon-Catheter, Model CC5500 Ref K022662
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow Jugular Puncture Kit 16 Ga. Ref K820009 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow-Fischell Extended Vascular Access Needle Ref K924338
Active Regimes: 510(k) Registry: 510(k) ClassClass:II14 Fr Two-Lumen Hemodialysis Catherization Kit With Blue Flextip Arrowg+ard Blue Catheter For High Volume Infusions, Pro Ref K993933 Open recall
Active Regimes: CE MDR 510(k) Registry: 510(k) ClassClass:IITwo-Lumen Central Venous Access Kit With Hemostasis Valve/Side Port Ref K002507 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow-Howes Large Bore Multi-Lumen Central Venous Catheters Ref K970864 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
Arrow Radial Artery Catheterization Set Ref K810675 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIMac Two-Lumen Central Venous Kit With Arrowg Ard Blue Antimicrobial Surface And Integral Hemostasis Valve/Side Port Ref K011761 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow-Trerotola Ptd Catheter Ref K970080
Active Regimes: 510(k) Registry: 510(k) ClassClass:IIArrow Positive Placement Con/Epidural An Ref K801912 Open recall
Active Regimes: 510(k) Registry: 510(k) ClassClass:II- Active Regimes: 510(k) Registry: 510(k) ClassClass:II
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