ACISTCVi® Contrast Delivery System
by ACIST Medical Systems, Inc.
510(k) K171646
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171646 | Date16 Feb 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXT
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1650
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The ACIST CVi Contrast Delivery System is an angiographic injector and syringe device designed for precise contrast media delivery during coronary angiography procedures. It automates the injection of contrast agents to enhance image clarity and procedural efficiency in cardiovascular imaging.
This system is intended for use in clinical settings where contrast media must be administered rapidly and accurately. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K171646) and classified as a Class II device (DXT, regulation number 870.1650). Multiple model and reference codes are associated with its regulatory submissions, reflecting its application across various angiographic workflows.
From the manufacturer
The CVi Contrast Delivery System simplifies contrast media injection for coronary angiography. Improve patient safety and image quality.
ACIST Medical Systems provides innovative products for interventional cardiologists including the CVi Contrast Delivery System.
Other devices from ACIST Medical Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
Is the ACIST CVi® Contrast Delivery System designed for single-use or can it be reused in multiple procedures?
The ACIST CVi® Contrast Delivery System is explicitly described as a reusable medical device. This means it is engineered for repeated use across multiple angiographic procedures, provided it is properly cleaned, maintained, and sterilized between uses according to manufacturer guidelines.
What types of procedures is this device intended to support, and why is precise contrast delivery important?
The ACIST CVi® Contrast Delivery System is designed specifically for coronary angiography, a procedure used to visualize the blood vessels of the heart. Precise contrast delivery is critical because it enhances image clarity, ensuring accurate diagnosis of coronary artery blockages or abnormalities while improving procedural efficiency and patient safety.
How is the regulatory status of this device defined, and what does that mean for clinicians?
The device holds FDA 510(k) clearance (K171646) and is classified as a Class II medical device under regulation number 870.1650. This means it has undergone rigorous review by the FDA to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets established safety and performance standards for use in clinical settings.
Are there multiple models or configurations of this device, and how might that affect my purchase decision?
While the device description does not specify exact model variations, the multiple product codes (e.g., 3002808086, 1000208624) listed in the regulatory submission indicate it may be available in different configurations or variants. These could correspond to features like flow rates, syringe sizes, or software updates tailored for specific angiographic workflows. Contacting the manufacturer would clarify which models align with your procedural needs.