Medical Device Manufacturer · US , North Attleboro , MA

Sorin Group Deutschland GmbH - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2006
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sorin Group Deutschland GmbH Cardiovascular ✕
19 devices
1-12 of 19
Cleared Jun 08, 2017
Sorin Connect
K170460 · DXJ
Cardiovascular · 113d
Cleared Jan 31, 2014
SORIN FLEXTHERM
K140012 · DWC
Cardiovascular · 29d
Cleared Jul 23, 2013
SORIN CONNECT DATA MANAGEMENT SYSTEM
K131816 · DXJ
Cardiovascular · 33d
Cleared Sep 20, 2011
SORIN CENTRIFUGAL PUMP 5 (CP5)
K112225 · DWA
Cardiovascular · 48d
Cleared Jan 20, 2011
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
K103468 · DWA
Cardiovascular · 57d
Cleared Jan 20, 2011
SORIN C5 SYSTEM
K103762 · DTQ
Cardiovascular · 28d
Cleared Jan 18, 2011
STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
K103469 · KRL
Cardiovascular · 55d
Cleared Jan 06, 2011
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
K103168 · DRY
Cardiovascular · 71d
Cleared Dec 09, 2010
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
K101046 · DTX
Cardiovascular · 239d
Cleared Jan 15, 2010
SORIN C5 SYSTEM MODEL 58-00-00
K093882 · DTQ
Cardiovascular · 28d
Cleared Nov 05, 2009
SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM
K092463 · DTQ
Cardiovascular · 86d
Cleared Jul 15, 2009
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
K091008 · DWA
Cardiovascular · 97d
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