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FDA 510(k), K173452, EmboTrap ll Revascularization Device
FDA 510(k), K173452, EmboTrap ll Revascularization Device
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510(K) Number: K173452
Device Name: EmboTrap ll Revascularization Device
Manufacturer: Neuravi Ltd.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 11/06/2017
Decision Date: 05/09/2018
Regulation Medical Specialty: Cardiovascular
Device Name: EmboTrap ll Revascularization Device
Manufacturer: Neuravi Ltd.
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 11/06/2017
Decision Date: 05/09/2018
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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