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Acs Soft-Tip Coronary Infusion Catheter W/Sidehole

FDA 510(k)

Class II (US FDA 510(k))

510(k) K875269

by Advanced Cardiovascular Systems, Inc.

Identifiers

510(k) Number
K875269 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 Catheter W/Sidehole is a medical device designed to infuse medications or contrast agents directly into coronary arteries. The soft-tip design is intended to minimize trauma to vessel walls during delicate coronary interventions, while the sidehole feature facilitates the even distribution of infused substances.

This device is manufactured by Advanced Cardiovascular Systems, Inc. and received FDA 510(k) clearance under K875269. It is categorized under product code DQY for use in cardiovascular procedures.

Frequently asked questions

What is the primary purpose of the ACS Soft-Tip Coronary Infusion Catheter?

This catheter is specifically designed to infuse medications or contrast agents directly into the coronary arteries. It features a soft-tip design to help minimize potential trauma to vessel walls during delicate coronary interventions.

What is the function of the sidehole design on this catheter?

The sidehole feature is incorporated into the catheter design to facilitate the even distribution of infused substances, such as medications or contrast agents, once they reach the target site within the coronary artery.

What is the regulatory status of this infusion catheter?

The ACS Soft-Tip Coronary Infusion Catheter received FDA 510(k) clearance under K875269. It is categorized under product code DQY for use in cardiovascular procedures, having been determined to be substantially equivalent to existing devices.

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 Soft-Tip Coronary Infusion Catheter - Advanced Cardiovascular ..., Acs Soft-tip Coronary Infusion Catheter W/Sidehole, Acs Soft-tip Coronary Infusion Catheter W/Sidehole, ACS Soft-Tip Coronary Infusion Cath w Side Holes - Advanced ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Cardiovascular Systems, Inc.

Sources (1)

  • FDA 510(k) K875269 24 fields · synced Sep 24, 2026