Skip to content

Large Bore Splittable Introducer Kit

by Thomas Medical Products, Inc.

510(k) K043438

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Special NumberK043438 Date15 Feb 2005ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1577-2026 FDA Class I initiated 13 Feb 2026

    16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

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  • Withdrawn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, 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.

A large bore splittable introducer kit is a cardiovascular device used to facilitate the insertion of catheters or other instruments into blood vessels. It consists of a sheath with a splittable design that allows for removal after vessel access is achieved, minimizing trauma to the vessel wall.

This device is supplied non-sterile and is intended for single-use in cardiovascular procedures. It is manufactured by Thomas Medical Products, Inc., and received FDA 510(k) clearance under k-number K043438 on February 15, 2005, with product code DYB and advisory committee classification CV.

Other devices from Thomas Medical Products, Inc.

See all devices from Thomas Medical Products, Inc. →

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 large bore splittable introducer kit used for?

    The large bore splittable introducer kit is used to facilitate the insertion of catheters or other instruments into blood vessels during cardiovascular procedures, allowing for vessel access with reduced trauma due to its splittable sheath design that can be removed after access is achieved.

  • Is the large bore splittable introducer kit sterile or non-sterile when supplied?

    The device is supplied non-sterile, as stated in the device data, and must be sterilized by the user prior to use in accordance with appropriate medical device reprocessing protocols for single-use items.

  • Can the large bore splittable introducer kit be reused after a procedure?

    No, the device is intended for single-use only, as specified in the description, to prevent cross-contamination and ensure patient safety; reuse is not recommended or supported by its design or labeling.

  • What is the FDA clearance number for the large bore splittable introducer kit?

    The device received FDA 510(k) clearance under k-number K043438 on February 15, 2005, which is the specific regulatory authorization referenced in the device data for this product.