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Medtronic Vascular Hub Material Modification to the 5F and 8F Launcher Guide Catheters

by Medtronic, Inc.

510(k) K103386

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 · Special NumberK103386 Date11 Feb 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1564-2013 FDA Class II initiated 12 Jun 2013

    Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Medtronic Vascular - Hub Material Modification to the 5F and 8F Launcher(R) Guide Catheters
510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
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.

This device is a guide catheter with a hub material modification applied to the 5F and 8F Launcher guide catheters. It is intended for use in cardiovascular procedures to facilitate the delivery of diagnostic or therapeutic devices within the vasculature.

The device is supplied sterile and is intended for single-use. It is manufactured by Medtronic, Inc. and received FDA 510(k) clearance (K103386) on February 11, 2011, as substantially equivalent to a predicate device. The device is categorized under product code DQY and was reviewed by the Cardiovascular advisory committee.

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