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Creganna Tactx Lotus Introducer Set

by Creganna-Tactx Medical

510(k) K140338

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 NumberK140338 Date27 Aug 2014ClearedStatusActive

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  • Withdrawn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)

Full name
Creganna Tactx Lotus Introducer Set (Small), Creganna Tactx Lotus Introducer Set (Large)
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, 23 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 Creganna Tactx Lotus Introducer Set is a medical device designed to facilitate the introduction of catheters and other medical devices into the vascular system. It consists of a sheath and dilator, which are used to help minimize trauma to the vessel during insertion.

This device is available in small and large sizes and has received FDA 510(k) clearance under K140338. It is manufactured by Creganna-Tactx Medical and has been evaluated through in vitro testing to ensure reliable design and performance.

Other devices from Creganna-Tactx Medical

Questions

AI-generated answers, 23 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 Creganna Tactx Lotus Introducer Set?

    This device is designed to facilitate the introduction of catheters and other medical instruments into the vascular system. It utilizes a sheath and dilator system specifically engineered to help minimize trauma to the vessel during the insertion process.

  • What size options are available for this introducer set?

    The Creganna Tactx Lotus Introducer Set is available in two distinct size configurations, identified as the small and large sets, to accommodate different clinical requirements for vascular access.

  • What is the regulatory status of the Creganna Tactx Lotus Introducer Set?

    This device has received FDA 510(k) clearance under K140338. It was evaluated through a traditional submission process and determined to be substantially equivalent to existing devices within the cardiovascular product category.