Acs Soft-Tip Coronary Infusion Cath W/Side Holes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K883564 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 Acs Soft-Tip Coronary Infusion Cath W/Side Holes is a coronary infusion catheter with side holes, used for infusion in coronary applications. It is designed to deliver fluids or medications directly to the coronary arteries. The catheter features a soft tip, which is intended to reduce the risk of vascular damage. The device is classified under the product code DQY.
The Acs Soft-Tip Coronary Infusion Cath W/Side Holes is supplied by Advanced Cardiovascular Systems, Inc. and has been found to be substantially equivalent by the FDA. The device has a clearance type of Traditional and is associated with the k number K883564. It is intended for use in a clinical setting, but specific details regarding its sterility, reusability, and MRI safety are not provided.
Frequently asked questions
What is the ACS Soft-Tip Coronary Infusion Cath W/Side Holes used for?
It is used for infusion in coronary applications, delivering fluids or medications directly to the coronary arteries. The soft tip is intended to reduce the risk of vascular damage during placement or use.
How is the ACS Soft-Tip Coronary Infusion Cath W/Side Holes supplied and is it sterile or reusable?
The device is supplied by Advanced Cardiovascular Systems, Inc., but the provided data does not specify whether it is sterile, single-use, or reusable. No details on sterility or reusability are included in the device information.
What regulatory pathway was used for the ACS Soft-Tip Coronary Infusion Cath W/Side Holes?
The device received FDA 510(k) clearance through the Traditional pathway, with K number K883564, and was found to be substantially equivalent to a predicate device. The product code is DQY, and the advisory committee review was Cardiovascular (CV).
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: ACS: High Precision Motion Control Systems & Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K883564 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K883564 24 fields · synced Sep 23, 2026