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510(k) K823272

Device
VENOUS RESERVOIR BAG #BMR-1400
Applicant
BENTLEY LABORATORIES, INC.
510(k) number
K823272
Product code
DTN  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-30
Date received
1982-11-02
Regulation
870.4400
Classification name
Reservoir, Blood, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DTN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L.2025-12-22
K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L.2024-07-18
K241053MVR™ 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 mLMedtronic Cardiac Surgery2024-05-15
K223361BMR 1900 PHISIOSorin Group Italia S.R.L.2023-06-10
K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc.2017-03-17
K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F CSorin Group Italia S.R.L.2017-03-08
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

Legacy Summary#

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FDA Review#

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