FDA 510(k) Applications Submitted by Greatbatch Medical

FDA 510(k) Number Submission Date Device Name Applicant
K130559 03/04/2013 MOBICATH BI-DIRECTIONAL GUIDING SHEATH Greatbatch Medical
K122832 09/17/2012 MOBICATH TRANSSEPTAL NEEDLE Greatbatch Medical
K111644 06/13/2011 MOBICATH TRANSSEPTAL NEEDLE Greatbatch Medical
K101784 06/25/2010 MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX Greatbatch Medical
K102540 09/03/2010 PTFE PORTABLE INTRODUCER Greatbatch Medical
K093023 09/29/2009 PTFE PEELABLE INTRODUCER Greatbatch Medical
K181855 07/11/2018 RadialSeal Introducer Kit Greatbatch Medical
K110051 01/07/2011 RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT Greatbatch Medical
K112541 09/01/2011 Z FLEX-270TM STEERABLE SHEATH Greatbatch Medical
K093232 10/14/2009 OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER Greatbatch Medical


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