Acs Tourgide Guiding Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K953987 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 TourGuide Guiding Catheter is a percutaneous catheter designed to provide support and facilitate the delivery of interventional devices during percutaneous coronary interventions. It is used to navigate through the vascular system to reach coronary arteries.
This device is manufactured by Advanced Cardiovascular Systems, Inc. and is supplied as a single-use or reusable device depending on the specific model. The device has FDA 510(k) clearance with product code DQY and was cleared on December 7, 1995. It is available in various sizes and models as specified by the manufacturer.
Frequently asked questions
What is the ACS TourGuide Guiding Catheter used for?
The ACS TourGuide Guiding Catheter is designed to support and guide interventional devices through the vascular system during percutaneous coronary interventions (PCI). Its primary purpose is to navigate the catheter to coronary arteries, providing stability and facilitating the delivery of therapeutic devices like balloons or stents.
Is the ACS TourGuide Guiding Catheter single-use or reusable?
The ACS TourGuide Guiding Catheter is available in both single-use and reusable models, depending on the specific variant selected. The manufacturer offers flexibility to accommodate clinical workflows, though sterilization protocols must be followed if reusing the device to ensure safety and efficacy.
What sizes and models are available for the ACS TourGuide Guiding Catheter?
The ACS TourGuide Guiding Catheter comes in various sizes and models, tailored to different clinical needs and patient anatomies. The manufacturer specifies these variations to ensure compatibility with diverse coronary intervention procedures. For exact sizing details, refer to the product documentation or contact the manufacturer.
How is the ACS TourGuide Guiding Catheter supplied?
The ACS TourGuide Guiding Catheter is supplied as a sterile medical device, ready for immediate use in clinical settings. Sterility is maintained to ensure patient safety during procedures. The packaging and handling instructions should be followed to preserve sterility until deployment.
What regulatory clearance does the ACS TourGuide Guiding Catheter hold?
The ACS TourGuide Guiding Catheter holds FDA 510(k) clearance, classified under product code DQY, with a decision date of December 7, 1995. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, meeting regulatory requirements for safety and effectiveness.
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 TourGuide Guiding Catheter - Advanced Cardiovascular Systems | FDA ..., ACS TOURGIDE GUIDING CATHETER (K953987) — FDA 510(k) | Innolitics, K953987 FDA 510 (k) - ACS TOURGIDE GUIDING CATHETER
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K953987 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K953987 24 fields · synced Oct 1, 2026