FDA 510(k) Applications Submitted by KAREN A BROZOWSKI

FDA 510(k) Number Submission Date Device Name Applicant
K061958 07/11/2006 MEDTRONIC EXPORT XT CATHETER MEDTRONIC VASCULAR
K072990 10/24/2007 GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID MEDTRONIC INC.
K970021 01/03/1997 RUSCH SUPRAPUBIC TRAY RUSCH, INC.
K010068 01/08/2001 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM RUSCH INTL.
K000070 01/10/2000 FLOCATH RUSCH INTL.
K030559 02/21/2003 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM RUSCH INTL.
K990619 02/25/1999 RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE RUSCH INTL.
K000665 02/28/2000 TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER TFX MEDICAL, INC.
K010596 02/28/2001 RUSCH BRONCHUS BLOCKER KIT RUSCH INTL.
K020714 03/05/2002 RUSCH FLONEIL; FLOCATH INTROGEL RUSCH INTL.
K981008 03/18/1998 SIMAL CERVICAL STABILIZATION SYSTEM TOP SURGICAL PRODUCTS GMBH
K971334 04/10/1997 PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR PILLING WECK GROUP
K961837 05/13/1996 RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY RUSCH INTL.
K961840 05/13/1996 RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY RUSCH INTL.
K982614 07/27/1998 RUSCH POLYFLEX STENT KIT RUSCH INTL.
K982974 08/25/1998 DD URETERAL STENT, INTEGRAL STENT RUSCH INTL.
K983010 08/28/1998 SELF CATH SET/SAFETY CATH RUSCH INTL.
K963815 09/23/1996 REUSABLE TROCAR WITH SLEEVE (COMMON) PILLING WECK GROUP
K013266 10/01/2001 RUSCH POLYFLEX STENT KIT RUSCH INTL.
K964123 10/15/1996 REUSABLE TROCAR WITH SLEEVE (COMMON) PILLING WECK GROUP
K964450 11/06/1996 SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT PILLING WECK GROUP
K993786 11/08/1999 RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY RUSCH INTL.
K964575 11/14/1996 SYMPACATH HYDROGEL COATED FOLEY RUSCH INTL.
K965176 12/24/1996 PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS PILLING WECK GROUP


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