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Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

by Surgical Instrument Service and Savings, Inc.

510(k) K242225

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 NumberK242225 Date29 Nov 2024ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1320-2026 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-2612-2025 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  • Withdrawn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)

Full name
Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
510(k) Number
FDA Product Code
NLH
Device Class
Class II
Regulation
21 CFR Part 870.1220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a reprocessed catheter, recording, electrode, classified under FDA regulation 870.1220. It is designed for cardiovascular diagnostic procedures, enabling real-time recording of electrical activity within the heart via its integrated electrodes. The catheter’s steerable tip allows for precise navigation through coronary vessels, facilitating accurate data acquisition during electrophysiological studies or diagnostic angiography. Its reprocessed nature adheres to FDA-substantiated equivalency standards for safety and performance.

The reprocessed Abbott Inquiry Steerable Diagnostic Catheter is supplied as a single-use medical device, intended for use in controlled clinical settings such as cardiac catheterization labs. It is not intended for MRI use and must be handled under sterile conditions post-reprocessing. Sizes and configurations align with the original Abbott Inquiry model, as verified through FDA’s 510(k) clearance (K242225). Compliance with reprocessing standards ensures adherence to regulatory requirements for cardiovascular diagnostic tools, maintaining performance and sterility for patient safety.

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Questions

AI-generated answers, 1 Oct 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 catheter designed for cardiovascular diagnostic procedures. It features a steerable tip for precise navigation through coronary vessels, enabling real-time recording of electrical activity within the heart during electrophysiological studies or diagnostic angiography.

  • Is this device intended for single use?

    Yes, the Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter is supplied as a single-use medical device. It must be handled under sterile conditions post-reprocessing and is intended for use in controlled clinical settings such as cardiac catheterization labs.

  • What are the key specifications and regulatory details?

    The device is classified under FDA regulation 870.1220 and has received FDA 510(k) clearance (K242225) for substantially equivalent performance to the original Abbott Inquiry model. It is not intended for MRI use.

  • How is the device supplied?

    It is supplied as a single-use medical device. The reprocessing process ensures adherence to FDA-substantiated equivalency standards for safety and performance, maintaining sterility for patient safety.