FDA 510(k) Applications Submitted by MARYBETH GAMBER

FDA 510(k) Number Submission Date Device Name Applicant
K050015 01/04/2005 MODIFIED ACUMEN SHEATH, MODEL TTWO767 ACUMEN MEDICAL, INC.
K070051 01/04/2007 ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM ACUMEN MEDICAL, INC.
K070197 01/22/2007 ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY ACUMEN MEDICAL, INC.
K070396 02/12/2007 MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 ACUMEN MEDICAL, INC.
K110627 03/04/2011 NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER MARVAO MEDICAL DEVICES, LTD.
K091340 05/06/2009 THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 BOSTON SCIENTIFIC CORP.
K091510 05/22/2009 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 Boston Scientific Corporation
K051515 06/08/2005 MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 ACUMEN MEDICAL, INC.
K081739 06/19/2008 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT BOSTON SCIENTIFIC CORP.
K121933 07/02/2012 NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) MARVAO MEDICAL DEVICES, LTD.
K062084 07/21/2006 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 ACUMEN MEDICAL, INC.
K062145 07/27/2006 MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 ACUMEN MEDICAL, INC.
K042376 09/01/2004 ACUMEN SHEATH, MODEL TTW7807 ACUMEN MEDICAL, INC.
K042381 09/01/2004 CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 ACUMEN MEDICAL, INC.
K083374 11/13/2008 WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM BOSTON SCIENTIFIC CORP.
K053400 12/06/2005 ACUMEN SINGLE-LUMEN DELIVERY SHEATH ACUMEN MEDICAL, INC.
K083627 12/08/2008 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 Boston Scientific Corporation


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