Great Batch Medical - FDA 510(k) Cleared Devices
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Great Batch Medical Cardiovascular ✕
10 devices
Cleared
Jul 26, 2018
RadialSeal Introducer Kit
Cardiovascular
15d
Cleared
May 24, 2013
MOBICATH BI-DIRECTIONAL GUIDING SHEATH
Cardiovascular
81d
Cleared
Dec 19, 2012
MOBICATH TRANSSEPTAL NEEDLE
Cardiovascular
93d
Cleared
Feb 07, 2012
Z FLEX-270TM STEERABLE SHEATH
Cardiovascular
159d
Cleared
Feb 02, 2012
RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
Cardiovascular
391d
Cleared
Oct 03, 2011
MOBICATH TRANSSEPTAL NEEDLE
Cardiovascular
112d
Cleared
Nov 26, 2010
MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX
Cardiovascular
154d
Cleared
Nov 16, 2010
PTFE PORTABLE INTRODUCER
Cardiovascular
74d
Cleared
Mar 15, 2010
OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER
Cardiovascular
152d
Cleared
Oct 29, 2009
PTFE PEELABLE INTRODUCER
Cardiovascular
30d