Cleared Traditional

ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit

K191060 · Acist Medical Systems, Inc. · General Hospital
Jul 2019
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K191060 is an FDA 510(k) clearance for the ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Acist Medical Systems, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on July 18, 2019, 87 days after receiving the submission on April 22, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K191060 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2019
Decision Date July 18, 2019
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code DXT — Injector And Syringe, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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