C2000 Automated Manifold Kit
by ACIST Medical Systems, Inc.
510(k) K052744
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052744 | Date16 Dec 2005 | StatusActive |
Recalls
-
- Terminated Z-0744-2016
Reports related to ingress of air into the manifold.
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- Withdrawn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 C2000 Automated Manifold Kit is an Injector and Syringe, Angiographic device designed for automated contrast injection during angiographic procedures. It integrates with angiographic injection systems to deliver precise fluid volumes under controlled pressure, facilitating high-resolution imaging of the cardiovascular system.
This disposable, single-use kit includes a patient manifold, saline spike, 3-way pressure stopcock, high-pressure line, and syringe cap. Intended for use in MRI-unsafe environments, it is classified as a Class II device under FDA regulation 870.1650 and holds a FDA 510(k) clearance (K052744) with a Substantially Equivalent determination. Storage and handling follow standard sterile medical device protocols for patient-contact components.
Other devices from ACIST Medical Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the C2000 Automated Manifold Kit in angiographic procedures?
The C2000 Automated Manifold Kit is designed to automate the delivery of contrast media during angiographic imaging. It integrates with angiographic injection systems to provide precise, controlled fluid volumes under pressure, ensuring high-resolution visualization of the cardiovascular system. This helps streamline the procedure while maintaining accuracy in contrast injection.
Is the C2000 Automated Manifold Kit intended for use in MRI environments?
No, the C2000 Automated Manifold Kit is explicitly designed for use in MRI-unsafe environments. This means it should not be used in settings where MRI compatibility is required, as it may interfere with MRI equipment or pose safety risks.
How is the C2000 Automated Manifold Kit supplied, and is it reusable?
The C2000 Automated Manifold Kit is supplied as a disposable, single-use device. It includes components like a patient manifold, saline spike, 3-way pressure stopcock, high-pressure line, and syringe cap, all intended for one-time use only to maintain sterility and patient safety. Reuse is not recommended or supported.
What storage and handling precautions should be taken for the C2000 Automated Manifold Kit?
The C2000 Automated Manifold Kit follows standard sterile medical device protocols for patient-contact components. This means it should be stored in a clean, dry environment, protected from contamination, and handled with sterile techniques before use. Avoid exposure to moisture, extreme temperatures, or direct sunlight to preserve sterility and functionality.
What regulatory pathway does the C2000 Automated Manifold Kit follow, and what does this mean for its use?
The C2000 Automated Manifold Kit holds a FDA 510(k) clearance (K052744) with a *Substantially Equivalent* determination under classification 870.1650 (Injector and Syringe, Angiographic). This means it has been reviewed by the FDA and deemed comparable to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for its intended use in angiographic contrast injection procedures.