← Back to catalogue

VIA 17 Microcatheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162565

by Sequent Medical, Inc.

Identifiers

510(k) Number
K162565 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 VIA 17 Microcatheter is a Catheter, Percutaneous (product code DQY), designed for percutaneous transluminal passage and placement within the neuro, peripheral, and coronary vasculature. It facilitates the introduction of non-liquid interventional devices, such as coils or stents, and the infusion of diagnostic agents like contrast media. Its flexible tube structure enables precise navigation through vascular pathways, supporting both therapeutic and diagnostic procedures.

Supplied as a single-use device, the VIA 17 Microcatheter is intended for use in clinical settings requiring vascular access, including neurovascular, peripheral, and coronary interventions. It is regulated under FDA 510(k) clearance (K162565) and classified as a Class II device under Special Controls. The device’s specifications include a defined lumen size, though exact dimensions are not stated in the regulatory data. Sterility and handling instructions are not detailed in the provided context, but compliance with standard aseptic techniques is implied for procedural use.

Frequently asked questions

What is the VIA 17 Microcatheter used for?

The VIA 17 Microcatheter is designed for percutaneous transluminal passage through neuro, peripheral, and coronary blood vessels. It facilitates the delivery of non-liquid interventional devices—such as coils or stents—and the infusion of diagnostic agents like contrast media. Its flexible structure allows for precise navigation through complex vascular pathways, making it suitable for both therapeutic and diagnostic procedures in these specialized areas.

Is the VIA 17 Microcatheter single-use or reusable?

The VIA 17 Microcatheter is supplied as a single-use device. This design ensures sterility and safety for each procedure, reducing the risk of cross-contamination between patients. Single-use devices are also aligned with clinical best practices for vascular interventions, where sterility and procedural integrity are critical.

What types of procedures can the VIA 17 Microcatheter support?

The VIA 17 Microcatheter supports a range of interventional and diagnostic procedures across three key vascular systems: neurovascular (brain and spinal vessels), peripheral (limbs and extremities), and coronary (heart arteries). Its flexible lumen allows for the introduction of devices like coils or stents, as well as the delivery of contrast media for imaging. This versatility makes it valuable in both emergency and elective settings where precise vascular access is required.

How is the VIA 17 Microcatheter regulated?

The VIA 17 Microcatheter is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K162565. It is classified as a Class II device under Special Controls, indicating it meets stringent regulatory standards for safety and effectiveness in its intended use. The device’s classification reflects its role in high-stakes medical procedures where precision and reliability are essential.

What should clinicians consider when storing the VIA 17 Microcatheter?

While specific storage instructions are not detailed in the regulatory data, standard aseptic techniques should be followed to maintain sterility. The device should be stored in a clean, dry environment protected from contamination, extreme temperatures, and direct sunlight. Proper packaging should remain intact until immediate use to preserve its sterile condition, as single-use devices require careful handling to ensure procedural safety.

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: VIA Microcatheter by Sequent Medical, Inc. - lavascular.com, VIA 17 Microcatheter by SEQUENT MEDICAL, INC. | FDA 510 (k) Summary, K162565 FDA 510 (k) - VIA 17 Microcatheter, VIA 17 Microcatheter (K162565) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sequent Medical, Inc.

Sources (1)

  • FDA 510(k) K162565 24 fields · synced Oct 6, 2026