MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
FDA 510(k) clearance K162774 · decided 2017-02-10
Clearance details
- K-number
- K162774
- Device name
- MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-03
- Decision date
- 2017-02-10
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- DTR
- Device class
- 2
- Regulation number
- 870.4240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, 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.
Recalls involving this device
No recalls on record reference this clearance.
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