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FDA 510(k), K171646, ACISTCVi® Contrast Delivery System
FDA 510(k), K171646, ACISTCVi® Contrast Delivery System
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$149.00 USD
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510(K) Number: K171646
Device Name: ACISTCVi® Contrast Delivery System
Manufacturer: ACIST Medical Systems, Inc.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 06/05/2017
Decision Date: 02/16/2018
Regulation Medical Specialty: Cardiovascular
Device Name: ACISTCVi® Contrast Delivery System
Manufacturer: ACIST Medical Systems, Inc.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 06/05/2017
Decision Date: 02/16/2018
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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