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FDA 510(k), K142870, Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
FDA 510(k), K142870, Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
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510(K) Number: K142870
Device Name: Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
Manufacturer: PENUMBRA, INC.
Device Classification Name: peripheral mechanical thrombectomy with aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 10/01/2014
Decision Date: 05/26/2015
Regulation Medical Specialty: Cardiovascular
Device Name: Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
Manufacturer: PENUMBRA, INC.
Device Classification Name: peripheral mechanical thrombectomy with aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 10/01/2014
Decision Date: 05/26/2015
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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