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FDA 510(k), K193576, Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
FDA 510(k), K193576, Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
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$89.00 USD
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510(K) Number: K193576
Device Name: Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Device Classification Name: Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Regulation Number: 882.5600
Classification Product Code: POL
Date Received: 12/23/2019
Decision Date: 11/20/2020
Regulation Medical Specialty: Neurology
Device Name: Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Device Classification Name: Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Regulation Number: 882.5600
Classification Product Code: POL
Date Received: 12/23/2019
Decision Date: 11/20/2020
Regulation Medical Specialty: Neurology
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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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