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Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)

by Surgical Instrument Service and Savings, Inc.

510(k) K234064

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK234064 Date10 Sep 2024ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1325-2026 FDA Class I initiated 22 Dec 2025

    These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

    • Ongoing Z-2614-2025 FDA Class I initiated 31 Jul 2025

    Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

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  • Withdrawn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
OWQ
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter is a reprocessed intravascular ultrasound catheter designed for use with Siemens and GE systems. It provides real-time imaging of blood vessels and cardiac structures during diagnostic or interventional procedures.

This device is supplied sterile and intended for single use. It is classified as a Class II device under Special Controls and has received FDA 510(k) clearance (K234064). Proper storage and handling are required to maintain sterility and functionality.

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Questions

AI-generated answers, 25 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 this device used for?

    It is a reprocessed intravascular ultrasound catheter designed to provide real-time imaging of blood vessels and cardiac structures during diagnostic or interventional procedures.

  • How is the device supplied and is it sterile?

    The device is supplied sterile and is intended for single use. Proper storage and handling are required to maintain its sterility and functionality.

  • What systems is this catheter compatible with?

    This specific model is designed for use with Siemens systems. A separate model is available for use with GE systems.

  • What is the regulatory status of this device?

    It is a Class II device under Special Controls and has received FDA 510(k) clearance (K234064).