Atlas FDA

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

FDA 510(k) clearance K241053 · decided 2024-05-15

Clearance details

K-number
K241053
Device name
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
Decision
Substantially Equivalent
Date received
2024-04-17
Decision date
2024-05-15
Days to decision
28 days
Clearance type
Special
Product code
DTN
Device class
2
Regulation number
870.4400
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Quantum Perfusion Hybrid System (K241206)Spectrum Medical S.R.L.2024-07-18
BMR 1900 PHISIO (K223361)Sorin Group Italia S.R.L.2023-06-10
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (K170583)Medtronic, Inc.2017-03-17
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (K161733)Sorin Group Italia S.R.L.2017-03-08
Capiox Advance Hardshell Reservoir (K153143)Terumo Cardiovascular Systems Corporation2015-12-02
Intersept Filtered Cardiotomy Reservoir (K151110)Medtronic, Inc.2015-05-27
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH (K141432)Maquet Cardiopulmonary, AG2014-07-07
AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE (K141233)Medtronic, Inc.2014-06-12
INITARY BETTER BLADDER-PEDIATRIC (K140321)Circulatory Technology, Inc.2014-04-17
VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT (K132166)Maquet Cardiopulmonary, AG2013-10-30
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE (K132972)Medtronic, Inc.2013-10-28

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HALL EASY-FIT PROSTHETIC HEART VALVE (P790018/S051)Medtronic Cardiac Surgery2009-12-18
MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT (P790018/S052)Medtronic Cardiac Surgery2009-07-09
MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC (P790018/S050)Medtronic Cardiac Surgery2008-12-09
MEDTRONIC HALL PROSTHETIC HEART VALVE (P790018/S049)Medtronic Cardiac Surgery2008-09-09
MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT (P790018/S048)Medtronic Cardiac Surgery2008-06-26
MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT (P790018/S047)Medtronic Cardiac Surgery2007-01-24
MEDTRONIC HALL (P790018/S046)Medtronic Cardiac Surgery2006-11-07
MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT (P790018/S045)Medtronic Cardiac Surgery2003-11-28