FDA 510(k) Applications Submitted by W.L. GORE & ASSOCIATES,INC

FDA 510(k) Number Submission Date Device Name Applicant
K093791 12/10/2009 GORE DRYSEAL SHEATH W.L. GORE & ASSOCIATES,INC
K083266 11/05/2008 GORE BIO-A FISTULA PLUG W.L. GORE & ASSOCIATES,INC
K043056 11/05/2004 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC
K964067 10/10/1996 GORE IRRIGATION SET W.L. GORE & ASSOCIATES,INC
K964061 10/10/1996 GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) W.L. GORE & ASSOCIATES,INC
K960292 01/22/1996 GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS W.L. GORE & ASSOCIATES,INC
K970884 03/10/1997 RESOLUT REGENERATIVE MATERIAL W.L. GORE & ASSOCIATES,INC
K962624 07/05/1996 RESOLUT REGENERATIVE MATERIAL W.L. GORE & ASSOCIATES,INC
K013346 10/09/2001 GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE W.L. GORE & ASSOCIATES,INC
K024178 12/18/2002 VIATORR ENDOPROSTHESIS W.L. GORE & ASSOCIATES,INC
K014215 12/21/2001 VIABIL BILIARY ENDOPROSTHESIS W.L. GORE & ASSOCIATES,INC
K983525 10/08/1998 GORE REVOX THYROPLASTY IMPLANT W.L. GORE & ASSOCIATES,INC
K984534 12/21/1998 PRECLUDE ACUSEAL DURA SUBSTITUTE W.L. GORE & ASSOCIATES,INC
K960656 02/15/1996 GORE BURR HOLE COVER W.L. GORE & ASSOCIATES,INC
K981051 03/18/1998 SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES W.L. GORE & ASSOCIATES,INC
K961210 03/28/1996 SAM FACIAL IMPLANT W.L. GORE & ASSOCIATES,INC
K961802 05/09/1996 PRECLUDE SYNBLOC MEMBRANE W.L. GORE & ASSOCIATES,INC
K962241 06/11/1996 GORE SPHEREX IMPLANT W.L. GORE & ASSOCIATES,INC
K963619 09/10/1996 GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES W.L. GORE & ASSOCIATES,INC
K973594 09/22/1997 GORE RESOLUT XT REGENERATIVE MATERIAL W.L. GORE & ASSOCIATES,INC
K964761 11/27/1996 S.A.M. FACIAL IMPLANT W/INTRODUCER W.L. GORE & ASSOCIATES,INC
K955494 12/01/1995 GORE-TEX DUALMESH BIOMATERIAL WITH HOLES W.L. GORE & ASSOCIATES,INC
K961628 04/26/1996 MINI FLEX COIL W.L. GORE & ASSOCIATES,INC
K130215 01/29/2013 GORE ACUSEAL VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC
K061727 06/19/2006 GORE PRECLUDE VESSEL GUARD W.L. GORE & ASSOCIATES,INC
K062161 07/28/2006 GORE PROPATEN VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC
K053200 11/16/2005 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC
K081069 04/15/2008 GORE INFINIT MESH W.L. GORE & ASSOCIATES,INC
K083300 11/10/2008 GORE FLOW REVERSAL SYSTEM W.L. GORE & ASSOCIATES,INC
K103500 11/29/2010 GORE EMBOLIC FILTER W.L. GORE & ASSOCIATES,INC
K992189 06/29/1999 GORE-TEX DUALMESH BIOMATERIAL W.L. GORE & ASSOCIATES,INC
K000185 01/20/2000 GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) W.L. GORE & ASSOCIATES,INC
K010228 01/24/2001 GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES W.L. GORE & ASSOCIATES,INC
K960532 02/07/1996 PRECLUDE IMA SLEEVE W.L. GORE & ASSOCIATES,INC
K010936 03/28/2001 MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC
K001789 06/13/2000 SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC
K962401 06/21/1996 GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES W.L. GORE & ASSOCIATES,INC
K012098 07/05/2001 PRECLUDE PERICARDIAL MEMBRANE W.L. GORE & ASSOCIATES,INC
K022782 08/22/2002 DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL W.L. GORE & ASSOCIATES,INC
K955364 11/22/1995 SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC
K965038 12/17/1996 GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE W.L. GORE & ASSOCIATES,INC
K991602 05/10/1999 EPTFE RINGED GORE-TEX VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC
K991683 05/17/1999 PTFE RINGED GORE-TEX VASCULAR GRAFT W.L. GORE & ASSOCIATES,INC
K013648 11/05/2001 VIABAHN ENDOPROSTHESIS W.L. GORE & ASSOCIATES,INC
K023811 11/15/2002 MODIFICATION TO VIABAHN ENDOPROSTHESIS W.L. GORE & ASSOCIATES,INC
K955533 12/05/1995 DIASTAT VASCULAR ACCESS GRAFT W.L. GORE & ASSOCIATES,INC
K955532 12/05/1995 DIASTAT VASCULAR ACCESS GRAFT W.L. GORE & ASSOCIATES,INC
K984526 12/21/1998 ACUSEAL CARDIOVASCULAR PATCH W.L. GORE & ASSOCIATES,INC
K013810 11/15/2001 CARDIOVASCULAR ARRAY W.L. GORE & ASSOCIATES,INC
K031089 04/07/2003 GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY W.L. GORE & ASSOCIATES,INC
K023679 11/01/2002 GORE 3.0T TORSO ARRAY W.L. GORE & ASSOCIATES,INC


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