Great Batch Medical is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Great Batch Medical - FDA 510(k) Cleared Devices
Recent clearances: RadialSeal Introducer Kit
10
Total
10
Cleared
0
Denied
Great Batch Medical has 10 FDA 510(k) cleared cardiovascular devices. Based in Pymouth, US.
Historical record: 10 cleared submissions from 2009 to 2018.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Great Batch Medical
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