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FDA 510(k), K193244, Indigo Aspiration System – Lightning Aspiration Tubing
FDA 510(k), K193244, Indigo Aspiration System – Lightning Aspiration Tubing
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510(K) Number: K193244
Device Name: Indigo Aspiration System – Lightning Aspiration Tubing
Manufacturer: Penumbra, Inc.
Device Classification Name: peripheral mechanical thrombectomy with aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 11/25/2019
Decision Date: 03/13/2020
Regulation Medical Specialty: Cardiovascular
Device Name: Indigo Aspiration System – Lightning Aspiration Tubing
Manufacturer: Penumbra, Inc.
Device Classification Name: peripheral mechanical thrombectomy with aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 11/25/2019
Decision Date: 03/13/2020
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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