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APRO 55 Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K234115

by Alembic, LLC

Identifiers

510(k) Number
K234115 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 APRO 55 Catheter is an intermediate catheter designed for use in neurovascular procedures. It features a hydrophilic-coated distal segment to aid navigation through the vasculature. The device is constructed with stainless-steel and coil+braid reinforcements for flexibility and durability.

The catheter is introduced using standard catheterization techniques under fluoroscopic guidance, typically through a guide catheter or sheath and over a guidewire. It is supplied as a single-use device and should be stored in a dry, cool environment. The device is regulated under FDA 510(k) authorization with product code DQY.

Frequently asked questions

What clinical applications is the APRO 55 Catheter intended for?

It is designed for neurovascular procedures, where an intermediate catheter is needed to navigate cerebral vessels under fluoroscopic guidance. The hydrophilic coating helps it advance smoothly through tortuous anatomy, supporting interventions such as clot retrieval or aneurysm treatment.

How is the APRO 55 Catheter supplied and what are the storage requirements?

The device is provided as a sterile, single‑use unit. It should be stored in a dry, cool environment to maintain the integrity of the hydrophilic coating and the stainless‑steel/coil‑braid structure until the point of use.

Is the APRO 55 Catheter reusable or single‑use, and why?

It is a single‑use catheter. Reuse could compromise the hydrophilic coating, sterility, and mechanical properties, potentially increasing the risk of vessel injury or infection during subsequent procedures.

What materials and design features give the APRO 55 Catheter its flexibility and durability?

The catheter combines stainless‑steel with coil and braid reinforcements, providing a balance of flexibility for navigation and durability to resist kinking. The distal segment’s hydrophilic coating further reduces friction, facilitating smooth passage through the vasculature.

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: APRO®* 55 intermediate catheter - Medtronic, APRO®* catheter - Medtronic, PDF March 15, 2024 Alembic, LLC Most Responsible Person Regulatory ..., K234115 FDA 510(k) - APRO 55 Catheter | Alembic, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alembic, LLC

Sources (1)

  • FDA 510(k) K234115 24 fields · synced Sep 21, 2026