FDA.reportPublic FDA data

510(k) K241053

Device
MVR? Venous Reservoir Bag 800 mL; MVR? Venous Reservoir Bag 1600 mL; MVR? Venous Reservoir Bag with Cortiva? BioActive Surface 800 mL; MVR? Venous Reservoir Bag with Cortiva? BioActive Surface 1600 mL
Applicant
Medtronic Cardiac Surgery
510(k) number
K241053
Product code
DTN
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-15
Date received
2024-04-17
Regulation
870.4400
Classification name
Reservoir, Blood, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yidi Hou
Address
8200 Coral Sea St. N.E Mounds View MN US 55112 55112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K153143Capiox Advance Hardshell ReservoirTerumo Cardiovascular Systems Corporation2015-12-02
K151110Intersept Filtered Cardiotomy ReservoirMedtronic, Inc.2015-05-27
K141432NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSHMaquet Cardiopulmonary, AG2014-07-07
K141233AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACEMedtronic, Inc.2014-06-12
K140321INITARY BETTER BLADDER-PEDIATRICCirculatory Technology, Inc.2014-04-17
K132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTMaquet Cardiopulmonary, AG2013-10-30
K132972AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACEMedtronic, Inc.2013-10-28
K131103XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIRSorin Group Italia S.R.L.2013-06-06
K122914AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESEMedtronic, Inc.2013-01-09
K112771BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAGSorin Group Italia S.R.L.2011-10-14