Coronary Infusion Catheter (K831717)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K831717 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Coronary Infusion Catheter (K831717) is a medical device classified under the nomenclature for catheters, infusion (DQY). It is designed for the infusion of therapeutic agents directly into the coronary arteries, facilitating targeted drug delivery or perfusion support during cardiac procedures. This device aids in the administration of medications or fluids to specific coronary vessels, enhancing treatment precision in interventional cardiology.
The device is supplied as a single-use catheter and is intended for use in controlled clinical settings such as cardiac catheterization labs. It is regulated under the FDA’s 510(k) pathway, with clearance granted in 1983 under the traditional review process. No additional sterility or MRI safety information is specified in the available data. The device is identified by its unique K-number (K831717) and product code (DQY), ensuring traceability and regulatory compliance.
Frequently asked questions
What is the primary purpose of the Coronary Infusion Catheter in cardiac procedures?
The Coronary Infusion Catheter is specifically designed to deliver therapeutic agents—such as medications or fluids—directly into coronary arteries during interventional cardiology procedures. This targeted approach enhances precision in treatment, ensuring the drug or perfusion support reaches the intended coronary vessels efficiently.
Is the Coronary Infusion Catheter meant for repeated use in the same patient, or is it single-use only?
The device is explicitly supplied as a single-use catheter. This design ensures patient safety and sterility, as it is intended for use in controlled clinical settings like cardiac catheterization labs, where each procedure requires a sterile instrument.
How do I identify the correct model or version of this catheter if I need to order it?
The Coronary Infusion Catheter is uniquely identified by its K-number (K831717) and product code (DQY). These identifiers ensure traceability and help distinguish it from other infusion catheters, so always reference these when ordering or documenting usage.
What type of regulatory pathway was followed for FDA clearance of this catheter?
The device was cleared through the FDA’s 510(k) pathway under the traditional review process, with a decision of Substantially Equivalent (SESE) made by the Cardiovascular (CV) Advisory Committee in 1983. This means it was deemed comparable to a legally marketed predicate device at the time.
Are there any special storage requirements mentioned for this catheter?
The available data does not specify any unique storage conditions (e.g., temperature, humidity) for the Coronary Infusion Catheter. However, as a single-use medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until 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: Coronary Infusion Catheter - Advanced Cardiovascular Systems | FDA ..., Catheters | Abbott, CORONARY INFUSION CATHETER (K831717) — FDA 510(k) | Innolitics, Coronary Infusion Catheter w Sideholes - Advanced Cardiovascular ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831717 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K831717 24 fields · synced Sep 20, 2026