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
Medtronic Cardiac Surgery · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Mounds View
- Advisory committee description
- Cardiovascular
- Address 1
- 8200 Coral Sea St. N.E
- Statement or summary
- Summary
- Product code
- DTN
- Zip code
- 55112
- Applicant
- Medtronic Cardiac Surgery
- Decision date
- 2024-05-15
- Decision code
- SESE
- Country code
- US
- Advisory committee
- CV
- Contact
- Yidi Hou
- K number
- K241053
- State
- MN
- Date received
- 2024-04-17
- Review advisory committee
- CV
- Postal code
- 55112
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- 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
- Harmonized identifiers (openFDA)
- Device name
- Reservoir, Blood, Cardiopulmonary Bypass
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.4400
- Device class
- 2
- Registration number
- 1724474, 3008307705, 1718850, 3016746283, 1124841, 3019807891, 3002806603, 9612051, 3003752502, 3010084488, 3030125051, 1047843, 3004548776, 3004080795, 3015136750, 3011554160, 3007829657, 1625519, 1319639, 2184009, 3044156918, 9681834, 1928237, 8010026, 1643817, 2029275, 3009746061, 3005941719, 9617601, 2011171, 9680841, 3003661577
- FEI number
- 3002808327, 3008307705, 1718850, 2828, 3016746283, 3003094851, 3019807891, 3002806603, 3003752502, 3000204839, 3010084488, 1000306431, 3030125051, 1047843, 3004548776, 3004080795, 3015136750, 3011554160, 3005426550, 3007829657, 3002807111, 1625519, 1000116158, 3044156918, 1928237, 3002806457, 1643817, 1000138054, 3009746061, 3002534070, 2011171, 3003661577