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FDA 510(k), K180466, FlowTriever Retrieval/Aspiration System
FDA 510(k), K180466, FlowTriever Retrieval/Aspiration System
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510(K) Number: K180466
Device Name: FlowTriever Retrieval/Aspiration System
Manufacturer: Inari Medical, Inc.
Device Classification Name: peripheral mechanical thrombectomy with aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 02/21/2018
Decision Date: 05/17/2018
Regulation Medical Specialty: Cardiovascular
Device Name: FlowTriever Retrieval/Aspiration System
Manufacturer: Inari Medical, Inc.
Device Classification Name: peripheral mechanical thrombectomy with aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 02/21/2018
Decision Date: 05/17/2018
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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