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transGlideXT Expandable Introducer

by Transaortic Medical, Inc.

510(k) K181817

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK181817 Date26 Mar 2019ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2039-2020 FDA Class I initiated 12 May 2020

    Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

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  • Withdrawn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, 19 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 transGlideXT Expandable Introducer is a vascular introducer device classified under product code DYB, designed to facilitate the introduction of catheters or embolization coils into the femoral iliac arteries. It functions as a guide for percutaneous vascular interventions, expanding to provide stable access and support during procedural placement.

This device is supplied as a single-use medical instrument and is intended for use in interventional radiology or cardiology settings. It is cleared by the FDA under the 510(k) pathway as substantially equivalent to a predicate device, with no explicit mention of MRI safety or sterility conditions in the available data. The device is manufactured by Transaortic Medical, Inc., and its regulatory classification aligns with Class II special controls.

Other devices from Transaortic Medical, Inc.

Questions

AI-generated answers, 19 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 types of procedures is the transGlideXT Expandable Introducer designed to assist with in the body?

    The transGlideXT Expandable Introducer is specifically designed to assist in percutaneous vascular interventions within the femoral iliac arteries. It acts as a guide to help introduce catheters or embolization coils during procedures in interventional radiology or cardiology settings, providing stable access and support for precise placement.

  • Is the transGlideXT Expandable Introducer meant for repeated use, or is it intended to be used only once?

    The transGlideXT Expandable Introducer is supplied as a single-use medical instrument, meaning it is intended for one-time use in a procedure. Reuse is not recommended or supported by the manufacturer.

  • How is the transGlideXT Expandable Introducer regulated in the U.S., and what does that mean for its use?

    The transGlideXT Expandable Introducer is cleared by the FDA under the 510(k) pathway, meaning it has been determined to be substantially equivalent to a predicate device already on the market. This classification places it in Class II, subject to special controls, but does not imply additional safety guarantees beyond what the 510(k) review confirms. Clinicians should follow established protocols for vascular introducers in their practice.

  • What settings or specialties would typically use the transGlideXT Expandable Introducer during procedures?

    This device is intended for use in interventional radiology and cardiology settings, where precise vascular access is required. It is particularly useful for procedures involving the femoral iliac arteries, such as catheter placements or embolization coil deployments, where stable introducer support is critical.