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ScoutPro 8F, 7F and Slitter Tool Advanced

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072329

by Biotronik, Inc.

Identifiers

510(k) Number
K072329 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 ScoutPro 8F, 7F and Slitter Tool Advanced is a medical device designed for venous stenting procedures. It consists of a stent delivery system and a slitter tool that facilitates the placement and deployment of stents in venous vessels to maintain patency in narrowed or blocked veins.

This device is supplied as a system of accessories for use in clinical settings. It has received FDA 510(k) clearance under K072329. The system includes specific configurations for 8F and 7F sizes and features a slitter tool with a defined blade angle.

Frequently asked questions

What is the primary clinical purpose of the ScoutPro system?

The ScoutPro 8F, 7F and Slitter Tool Advanced is designed for use in venous stenting procedures. It functions as a stent delivery system that includes a specialized slitter tool to assist in the accurate placement and deployment of stents within narrowed or blocked venous vessels to help maintain vessel patency.

What size configurations are available for this device?

The system is provided in two specific size configurations, 8F and 7F, to accommodate different clinical requirements during venous stenting procedures. Each system includes the necessary delivery components and the slitter tool featuring a defined blade angle.

What is the regulatory status of the ScoutPro system?

The ScoutPro 8F, 7F and Slitter Tool Advanced has received FDA 510(k) clearance under K072329. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for its intended use in cardiovascular applications.

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: PDF BIOTRONIK Inc., Modifications to ScoutPro 8F Accessories Special 510(k ..., scoutpro 8f 7f and slitter tool advanced - Biotronik | FDA Reference, SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED (K072329) — FDA 510(k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K072329 24 fields · synced Sep 21, 2026