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Great Batch Medical

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K181855 RadialSeal Introducer KitDYB2018-07-26 View
510(k) K130559 MOBICATH BI-DIRECTIONAL GUIDING SHEATHDYB2013-05-24 View
510(k) K122832 MOBICATH TRANSSEPTAL NEEDLEDRC2012-12-19 View
510(k) K112541 Z FLEX-270TM STEERABLE SHEATHDRA2012-02-07 View
510(k) K110051 RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KITDYB2012-02-02 View
510(k) K111644 MOBICATH TRANSSEPTAL NEEDLEDRC2011-10-03 View
510(k) K101784 MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXXDYB2010-11-26 View
510(k) K102540 PTFE PORTABLE INTRODUCERDYB2010-11-16 View
510(k) K093232 OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCERDYB2010-03-15 View
510(k) K093023 PTFE PEELABLE INTRODUCERDYB2009-10-29 View
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