ACS Powerbase Coronary Guiding Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K940559 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 Powerbase Coronary Guiding Catheter is a coronary guiding catheter, classified under the FDA product code DQY. It is designed to facilitate coronary angiography and interventional procedures by providing support and stability for the precise delivery of therapeutic devices, such as balloons and stents, within the coronary arteries. Its construction emphasizes torque control and flexibility to enhance maneuverability and accuracy during cardiac interventions.
This device is intended for use in catheterization laboratories and is supplied as a single-use, non-sterile product. It requires sterilization prior to use, typically via ethylene oxide or gamma irradiation, and must be handled according to standard aseptic techniques. The catheter is regulated under the FDA’s 510(k) clearance process (K940559) and is classified as substantially equivalent to a predicate device. No MRI safety information is specified, and sizes or additional technical specifications are not provided in the available data.
Frequently asked questions
What is the ACS Powerbase Coronary Guiding Catheter designed for?
This catheter is specifically engineered to assist in coronary angiography and interventional procedures. Its primary purpose is to provide stable support and torque control during the delivery of therapeutic devices, such as balloons and stents, within coronary arteries. The design ensures enhanced maneuverability and accuracy, which are critical for successful interventions in catheterization labs.
How is the ACS Powerbase Coronary Guiding Catheter supplied and prepared for use?
The ACS Powerbase Coronary Guiding Catheter is supplied as a single-use, non-sterile product. Before use, it must be sterilized using methods like ethylene oxide or gamma irradiation. Sterilization ensures safety and compliance with aseptic techniques, which are essential for preventing infection during cardiac procedures.
Is the ACS Powerbase Coronary Guiding Catheter reusable or intended for single use?
This catheter is explicitly intended for single-use only. After sterilization, it should not be reused, as repeated use could compromise sterility and integrity, potentially leading to complications during procedures. Adherence to single-use guidelines ensures patient safety and procedural reliability.
What regulatory pathway does the ACS Powerbase Coronary Guiding Catheter follow?
The ACS Powerbase Coronary Guiding Catheter is regulated under the FDA’s 510(k) clearance process, classified as substantially equivalent to a predicate device. This pathway confirms that the device meets established safety and performance standards for coronary guiding catheters, ensuring its suitability for clinical use in catheterization labs.
Are there any specific storage instructions for the ACS Powerbase Coronary Guiding Catheter?
While the provided data does not specify detailed storage instructions, it is standard practice to store single-use medical devices in a clean, dry environment protected from contamination and physical damage. After sterilization, the catheter should be stored according to manufacturer guidelines to maintain its integrity until immediate use, ensuring optimal performance during procedures.
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 Powerbase TM Coronary Guiding Catheter - Advanced Cardiovascular ..., ACS POWERBASE(TM) CORONARY GUIDING CATHETER (K940559) — FDA 510(k ..., K940559 - Acs Powerbase (Tm) Coronary Guiding Catheter, ACS POWERBASE(TM) CORONARY GUIDING CATHETER (K940559) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K940559 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K940559 24 fields · synced Oct 1, 2026