Name: Predicase
Price: 199 USD

K-number	K191060
Device name	ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
Applicant	Acist Medical Systems, Inc.
Product code	DXT
Device class	Class II
Decision date	Jul 18, 2019
Decision	Substantially Equivalent
Regulation	870.1650

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.