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FDA 510(k)

ACISTCVi® Contrast Delivery System

K-Number: K171646 · 2018-02-16

ApplicantAcist Medical Systems, Inc.
Decision Date2018-02-16
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACISTCVi® Contrast Delivery System is a medical device manufactured by Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-02-16 under approval number K171646. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACISTCVi® Contrast Delivery System?

ACISTCVi® Contrast Delivery System is a medical device that received FDA 510(k) clearance on 2018-02-16. It is manufactured by Acist Medical Systems, Inc.. The 510(k) number is K171646.

When was ACISTCVi® Contrast Delivery System approved by the FDA?

ACISTCVi® Contrast Delivery System received FDA 510(k) clearance on 2018-02-16, under approval number K171646.

What company makes ACISTCVi® Contrast Delivery System?

ACISTCVi® Contrast Delivery System is manufactured by Acist Medical Systems, Inc..

What is the FDA product code for ACISTCVi® Contrast Delivery System?

The FDA product code for ACISTCVi® Contrast Delivery System is DXT.

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Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024)

Other Devices by Acist Medical Systems, Inc.

K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System K172216ACIST RXi Mini System K190473ACIST RXi System and Navvus II Catheter K191060ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System

View all 11 devices →

Related Devices (Code: DXT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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