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Paragon 8F Balloon Guide Catheter

by Wallaby Medical 510(k)

Active United States

510(k) K232437

Overview

The Paragon 8F Balloon Guide Catheter is a Balloon Guide Catheter (DQY), designed to assist in the delivery and positioning of venous stents during endovascular interventions. It features an 8 French lumen size and an integrated balloon mechanism to facilitate precise stent deployment in vascular procedures.

This device is supplied sterile and intended for single-use. It is classified as a Class 2 medical device with FDA 510K clearance (K232437) under the Traditional 510(k) pathway, determined as substantially equivalent to the predicate device. The catheter is distributed commercially and must be stored as directed to maintain sterility and functionality.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232437 Date13 Oct 2023ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the Paragon 8F Balloon Guide Catheter in medical procedures?

    The Paragon 8F Balloon Guide Catheter is specifically designed to assist in the delivery and precise positioning of venous stents during endovascular interventions. Its integrated balloon mechanism helps facilitate accurate stent deployment within vascular structures.

  • Is the Paragon 8F Balloon Guide Catheter intended for reuse, or is it meant for single-use only?

    The Paragon 8F Balloon Guide Catheter is explicitly intended for single-use only, as stated in its design and supply specifications. This ensures patient safety and maintains sterility for each procedure.

  • How should the Paragon 8F Balloon Guide Catheter be stored to ensure it remains functional and sterile?

    The device must be stored as directed by the manufacturer to preserve sterility and functionality. While specific storage instructions are not detailed here, it is generally recommended to follow the included packaging guidelines or manufacturer’s instructions to avoid contamination or damage.

  • What French lumen size does the Paragon 8F Balloon Guide Catheter have, and how does this affect its use?

    The Paragon 8F Balloon Guide Catheter features an 8 French lumen size, which refers to the diameter of the catheter’s inner channel. This size is standard for venous procedures and ensures compatibility with common venous access points while providing sufficient space for stent delivery and balloon inflation.

  • How was the regulatory pathway for the Paragon 8F Balloon Guide Catheter determined, and what does this mean for its use?

    The device was cleared via the Traditional 510(k) pathway under the FDA’s Substantially Equivalent (SESE) determination, meaning it was found to be equivalent to a predicate device already on the market. This classification places it as a Class 2 medical device, indicating it carries moderate regulatory oversight but is commercially available for approved endovascular applications.