FDA 510(k) Applications Submitted by ARROW INTL., INC.

FDA 510(k) Number Submission Date Device Name Applicant
K960572 02/07/1996 THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER ARROW INTL., INC.
K961583 04/24/1996 A PORT DETACHED CATHETER SYSTEM CATALOG #1002 ARROW INTL., INC.
K961615 04/26/1996 LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037 ARROW INTL., INC.
K961652 04/30/1996 LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017 ARROW INTL., INC.
K981782 05/20/1998 LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM ARROW INTL., INC.
K021723 05/24/2002 SHEATH ADAPTER, MODEL SA-09847 ARROW INTL., INC.
K093050 09/30/2009 ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 ARROW INTL., INC.
K021120 04/08/2002 RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP ARROW INTL., INC.
K041153 05/03/2004 SHARPSAWAY II LOCKING DISPOSABLE CUP ARROW INTL., INC.
K032962 09/23/2003 AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE ARROW INTL., INC.
K963684 08/12/1996 A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED) ARROW INTL., INC.
K060309 02/07/2006 AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES ARROW INTL., INC.
K071111 04/20/2007 NON-ABSORBABLE SILK SUTURE ARROW INTL., INC.
K071491 05/30/2007 ARROW INTERNATIONAL, INC., SURGICAL DRAPES ARROW INTL., INC.
K071998 07/23/2007 ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT ARROW INTL., INC.
K965209 12/27/1996 ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) ARROW INTL., INC.
K961088 03/19/1996 NON-CORING NEEDLE ARROW INTL., INC.
K955819 12/26/1995 A2 DETACHED DUAL PORT SYSTEM ARROW INTL., INC.
K042126 08/06/2004 PICC ARROW INTL., INC.
K022662 08/09/2002 DIATEK CANNON-CATHETER, MODEL CC5500 ARROW INTL., INC.
K970080 01/09/1997 ARROW-TREROTOLA PTD CATHETER ARROW INTL., INC.
K970229 01/21/1997 ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET ARROW INTL., INC.
K960479 02/02/1996 ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER ARROW INTL., INC.
K960713 02/21/1996 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH) ARROW INTL., INC.
K970689 02/25/1997 IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U ARROW INTL., INC.
K970864 03/10/1997 ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS ARROW INTL., INC.
K990829 03/12/1999 ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 ARROW INTL., INC.
K011056 04/06/2001 ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD ARROW INTL., INC.
K961358 04/08/1996 ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER ARROW INTL., INC.
K991431 04/26/1999 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT ARROW INTL., INC.
K001587 05/23/2000 19 GA PLASTIC REINFORCED EPIDURAL CATHETER ARROW INTL., INC.
K011761 06/06/2001 MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT ARROW INTL., INC.
K982141 06/17/1998 ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 ARROW INTL., INC.
K962577 07/01/1996 ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER ARROW INTL., INC.
K963104 08/09/1996 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM ARROW INTL., INC.
K953746 08/10/1995 ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET ARROW INTL., INC.
K002507 08/15/2000 TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT ARROW INTL., INC.
K963257 08/19/1996 PERIPHERALLY INSERTED MEDLINE CATHETER ARROW INTL., INC.
K963865 09/24/1996 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S ARROW INTL., INC.
K003006 09/26/2000 TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION ARROW INTL., INC.
K963920 09/30/1996 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER, ARROW INTL., INC.
K993691 11/01/1999 ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER ARROW INTL., INC.
K984022 11/12/1998 PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT ARROW INTL., INC.
K993933 11/18/1999 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO ARROW INTL., INC.
K100635 03/05/2010 ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 ARROW INTL., INC.
K010330 02/02/2001 ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U ARROW INTL., INC.
K000729 03/06/2000 ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL ARROW INTL., INC.
K040801 03/29/2004 INTRA-AORTIC BALLOON (IAB) ARROW INTL., INC.
K021462 05/07/2002 ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840 ARROW INTL., INC.
K002256 07/25/2000 ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP ARROW INTL., INC.
K993966 11/23/1999 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER ARROW INTL., INC.
K040100 01/20/2004 ARROW ECHOGENIC INTRODUCER NEEDLE ARROW INTL., INC.
K040802 03/29/2004 HEMOSONIC 200HEMODYNAMIC MONITOR ARROW INTL., INC.
K031153 04/11/2003 MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 ARROW INTL., INC.
K021567 05/13/2002 STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 ARROW INTL., INC.


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