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FDA 510(k), K161879, Solitaire Platinum Revascularization Device
FDA 510(k), K161879, Solitaire Platinum Revascularization Device
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510(K) Number: K161879
Device Name: Solitaire Platinum Revascularization Device
Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 07/08/2016
Decision Date: 09/21/2016
Regulation Medical Specialty: Cardiovascular
Device Name: Solitaire Platinum Revascularization Device
Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Device Classification Name: catheter, thrombus retriever
Regulation Number: 870.1250
Classification Product Code: NRY
Date Received: 07/08/2016
Decision Date: 09/21/2016
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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