Atlas FDA

Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface

FDA 510(k) clearance K170583 · decided 2017-03-17

Clearance details

K-number
K170583
Device name
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2017-02-28
Decision date
2017-03-17
Days to decision
17 days
Clearance type
Special
Product code
DTN
Device class
2
Regulation number
870.4400
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Inspire HCR and HCR DUAL cardiotomy reservoirs (K251783)Sorin Group Italia S.R.L.2025-12-22
Quantum Perfusion Hybrid System (K241206)Spectrum Medical S.R.L.2024-07-18
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 (K241053)Medtronic Cardiac Surgery2024-05-15
BMR 1900 PHISIO (K223361)Sorin Group Italia S.R.L.2023-06-10
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.

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