Identifiers
- 510(k) Number
- K042489 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 6F Z4 Guide Catheter is a percutaneous vascular catheter classified as a guide catheter (FDA Product Code: DQY). It is designed to establish a stable, low-profile lumen for the introduction and advancement of therapeutic devices, such as balloons or stents, within the coronary or peripheral vascular system. Constructed with a 6 French outer diameter, it incorporates a soft tip, tungsten/nylon band, and reinforced layers—including a stainless steel braided wire and Pebax intermediate layer—to ensure durability and navigability. Its design supports precise catheterization for interventional procedures.
This device is supplied as a single-use, non-sterile catheter, intended for use in controlled clinical settings such as cardiac catheterization labs or interventional radiology suites. It requires terminal sterilization prior to use and must be handled with sterile technique. The 6F sizing is standard for coronary interventions, and its braided construction enhances torque control and pushability. Authorized under FDA 510(k) clearance (K042489), it adheres to cardiovascular device standards and is intended for use by trained professionals in vascular interventions.
Frequently asked questions
Is the 6F Z4 Guide Catheter intended for use in both coronary and peripheral vascular procedures, and how does its design support this versatility?
Yes, the 6F Z4 Guide Catheter is designed for use in both coronary and peripheral vascular systems. Its 6 French outer diameter is standard for coronary interventions, while its reinforced construction—including a soft tip, tungsten/nylon band, and braided stainless steel wire—enhances navigability and torque control, making it suitable for navigating through varied vascular anatomies. The Pebax intermediate layer further supports durability and precision during catheterization, ensuring stability for advancing therapeutic devices like balloons or stents.
How should the 6F Z4 Guide Catheter be prepared for use, and why is terminal sterilization required?
The 6F Z4 Guide Catheter is supplied as a single-use, non-sterile device, meaning it must undergo terminal sterilization before clinical use. This process ensures sterility and safety in controlled settings like cardiac catheterization labs or interventional radiology suites, where sterile technique is mandatory. Terminal sterilization is required because non-sterile devices cannot be safely used in invasive procedures without proper sterilization.
What are the key features of the 6F Z4 Guide Catheter’s construction that improve its performance during interventional procedures?
The catheter’s design incorporates several performance-enhancing features: a soft tip for gentle vessel navigation, a tungsten/nylon band for added strength, and a stainless steel braided wire combined with a Pebax intermediate layer to improve torque control and pushability. These elements collectively ensure durability, precision, and stability when advancing therapeutic devices like balloons or stents through coronary or peripheral vessels.
Is the 6F Z4 Guide Catheter reusable, or is it intended for single-use only? What does this mean for clinical workflows?
The 6F Z4 Guide Catheter is intended for single-use only, as explicitly stated in its description. This means each catheter is designed for one procedure and must not be reused, even after sterilization. Clinically, this ensures patient safety by preventing potential contamination or degradation from repeated use, while also streamlining workflows by eliminating the need for reprocessing or validation of reuse.
What regulatory pathway was followed for the FDA clearance of the 6F Z4 Guide Catheter, and which advisory committee was involved?
The 6F Z4 Guide Catheter received FDA 510(k) clearance under the classification of a guide catheter (Product Code: DQY), with a substantially equivalent determination. The review was conducted by the Cardiovascular (CV) Advisory Committee, and the clearance was granted on December 13, 2004, following a special review process. This pathway ensures the device meets established safety and effectiveness standards for vascular interventions.
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: 6F Z4 GUIDE CATHETER (K042489) — FDA 510 (k) | Innolitics, 6f z4 Guide Catheter - Medtronic Vascular | FDA Reference, Launcher™ guide catheter - Medtronic, K042489 - 6F Z4 GUIDE CATHETER | FDA 510(k) | Medtronic Vascular
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042489 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K042489 24 fields · synced Oct 6, 2026