Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
FDA 510(k) clearance K191077 · decided 2019-08-27
Clearance details
- K-number
- K191077
- Device name
- Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-23
- Decision date
- 2019-08-27
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- 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
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Recalls involving this device
No recalls on record reference this clearance.
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