Atlas FDA

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

FDA 510(k) clearance K162958 · decided 2017-02-01

Clearance details

K-number
K162958
Device name
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2016-10-24
Decision date
2017-02-01
Days to decision
100 days
Clearance type
Traditional
Product code
DTR
Device class
2
Regulation number
870.4240
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
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Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger (K212688)Qura S.R.L2022-01-10
MPS 3 ND Myocardial Protection System (K201984)Quest Medical, Inc.2020-11-20
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MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) (K162774)Medtronic, Inc.2017-02-10
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Recalls involving this device

No recalls on record reference this clearance.

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