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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