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FDA 510(k), K203004, ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
FDA 510(k), K203004, ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
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$149.00 USD
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510(K) Number: K203004
Device Name: ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
Manufacturer: Jeff Koll
Device Classification Name: Injector And Syringe, Angiographic
Regulation Number: DXT
Classification Product Code: 10/01/2020
Date Received: 12/17/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
Manufacturer: Jeff Koll
Device Classification Name: Injector And Syringe, Angiographic
Regulation Number: DXT
Classification Product Code: 10/01/2020
Date Received: 12/17/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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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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