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SoloPath Re-Collapsible Access System

by Onset Medical Corporation 2 variants

510(k) K152498

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152498 Date5 Jan 2016ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1375-2019 FDA Class I initiated 26 Apr 2019
    • Terminated Z-1376-2019 FDA Class I initiated 26 Apr 2019

    There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SoloPath Re-Collapsible Access System is an introducer catheter designed for percutaneous insertion into the femoral artery over a guidewire. Once expanded, the device provides a guide for the introduction of catheters and other medical devices into the femoral artery.

This device consists of a flexible, reinforced polymer sheath and is supplied as a sterile, single-use product. It has received FDA 510(k) clearance as a Class II medical device under product code DYB.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the SoloPath Re-Collapsible Access System?

    This device is an introducer catheter designed for percutaneous insertion into the femoral artery over a guidewire. Once expanded, it serves as a guide to facilitate the introduction of other catheters and medical devices into the artery.

  • Is the SoloPath Re-Collapsible Access System intended for reuse?

    No, this device is supplied as a sterile, single-use product. It is designed to be used for a single procedure and must be discarded afterward to maintain patient safety and device integrity.

  • What are the construction materials of this access system?

    The SoloPath Re-Collapsible Access System is constructed using a flexible, reinforced polymer sheath. This material composition is designed to provide the necessary flexibility and structural support required for femoral artery access.

  • What is the regulatory status of this device?

    The SoloPath Re-Collapsible Access System has received FDA 510(k) clearance as a Class II medical device under product code DYB. This indicates that the device has been found substantially equivalent to legally marketed predicate devices.