FDA 510(k) Applications Submitted by THOMAS D NICKEL

FDA 510(k) Number Submission Date Device Name Applicant
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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact