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Cross-Pilot Turbo Elite Support Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082559

by Spectranetics Corp.

Identifiers

510(k) Number
K082559 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 Cross-Pilot Turbo Elite Support Catheter is a vascular support catheter classified under the nomenclature for guide and support catheters. It is designed to guide and stabilize laser catheters during vascular access procedures, facilitating the delivery of saline or contrast agents through the venous system.

This catheter is intended for use in interventional cardiology settings and is supplied as a single-use device. It is intended to assist in navigating complex venous anatomy, particularly during procedures involving venous stents. The device holds an FDA 510(k) clearance under the product code DQY, with a traditional review pathway and substantial equivalence determination.

Frequently asked questions

What is the primary purpose of the Spectranetics Cross-Pilot Turbo Elite Support Catheter in clinical procedures?

The Spectranetics Cross-Pilot Turbo Elite Support Catheter is designed to guide and stabilize laser catheters during vascular access procedures, particularly in complex venous anatomy. It helps facilitate the delivery of saline or contrast agents through the venous system, ensuring smoother navigation and support during interventions like venous stent placement.

Is this catheter reusable or intended for single-use only, and how does that affect its clinical workflow?

This catheter is explicitly supplied as a single-use device, meaning it is intended for one-time use only. This design choice reduces the risk of contamination and cross-infection, simplifying workflow by eliminating the need for reprocessing or sterilization between procedures.

What type of interventional cardiology procedures is this catheter most commonly used for?

The catheter is specifically intended for use in interventional cardiology settings where navigating complex venous anatomy is challenging, such as during procedures involving venous stents. Its primary role is to assist in stabilizing laser catheters and ensuring precise delivery of fluids.

How is the Spectranetics Cross-Pilot Turbo Elite Support Catheter regulated, and what does that mean for clinicians?

The catheter holds an FDA 510(k) clearance under product code DQY, determined through a traditional review pathway with a substantial equivalence determination by the Cardiovascular Advisory Committee. This means it has been evaluated and deemed comparable to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness.

What should clinicians consider when storing this catheter to maintain its integrity?

Since the device is single-use and intended for sterile use, clinicians should store it in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures sterility and prevents damage to the catheter’s delicate components before use.

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: Spectranetics Cross-pilot Turbo Elite Support Catheter, spectranetics cross-pilot turbo elite support catheter, PDF 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spectranetics Corp.

Sources (1)

  • FDA 510(k) K082559 24 fields · synced Sep 19, 2026