125mL CT Syringe
FDA 510(k)Class II (US FDA 510(k))
by Coeur, Inc.
Identifiers
- 510(k) Number
- K142745 FDA 510(k)
- FDA Product Code
- DXT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1650 FDA 510(k)
- Regulation Number
- 870.1650 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 125mL CT Syringe is an angiographic injector and syringe device designed for use in cardiovascular procedures. It is constructed from clarified polypropylene or PET to facilitate the detection of air bubbles and features a dual-seal plunger to prevent air aspiration or leakage.
This device is supplied with 60-inch coiled tubing, a transfer spike, and a fill straw. It is intended for use with compatible injectors, including the Liebel-Flarsheim CT 9000, CT9000ADV, Angiomat 6000 CT, and Angiomat Illumena systems. The device has received FDA 510(k) clearance.
Frequently asked questions
What is the primary purpose of the 125mL CT Syringe?
This device is an angiographic injector and syringe intended for use during cardiovascular procedures to deliver contrast media.
Which injector systems are compatible with this syringe?
The syringe is designed for use with specific Liebel-Flarsheim systems, including the CT 9000, CT9000ADV, Angiomat 6000 CT, and Angiomat Illumena.
What components are included with the device supply?
Each unit is supplied with the 125mL syringe, 60-inch coiled tubing, a transfer spike, and a fill straw to facilitate the setup process.
How does the design assist in clinical safety?
The syringe is constructed from clarified polypropylene or PET to allow for the detection of air bubbles, and it incorporates a dual-seal plunger to prevent air aspiration or leakage during use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: C8530126 Syringe 125ml 60in Coiled Tube Transfer Spike Fill Straw ( Ea 1 ), 125mL CT Syringe by COEUR, INC. | FDA 510 (k) Summary, Coeur Coeur CT Syringe 125 mL, Polypropylene, 60 Inch Coil Tube Liebel ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142745 | Class II | Active |
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Manufacturer
- Manufacturer
- Coeur, Inc.
Sources (1)
- FDA 510(k) K142745 24 fields · synced Sep 21, 2026