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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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