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Solopath Re-Collapsible Access System

by Onset Medical Corporation 2 variants

510(k) K121404

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK121404 Date3 May 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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, 21 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 a vascular access device designed for percutaneous procedures. It provides a pathway for accessing blood vessels during cardiovascular interventions.

This device is supplied as a single-use system and is not intended for reuse. It is regulated under FDA 510K clearance with product code DYB and is designed for use in cardiovascular procedures.

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Questions

AI-generated answers, 21 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 SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM used for?

    The SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM is a vascular access device designed for percutaneous procedures, providing a pathway for accessing blood vessels during cardiovascular interventions.

  • Is the SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM reusable or single-use?

    This device is supplied as a single-use system and is not intended for reuse. Each unit should be discarded after a single procedure to ensure patient safety and device performance.

  • What regulatory approvals does the SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM have?

    The device is regulated under FDA 510K clearance with product code DYB. It received clearance on May 3, 2013, after being submitted on May 10, 2012, with the decision code SESE indicating substantial equivalence.

  • What sizes and models of the SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM are available?

    The device data does not specify available sizes or models. For detailed information about available configurations, please contact the manufacturer directly at Onset Medical Corporation in Irvine, CA.