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TrailBlazer Angled Support Catheter

by Medtronic Vascular, Inc.(Formerly Ev3 Inc.)

510(k) K162384

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 NumberK162384 Date22 Sep 2016ClearedStatusActive

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  • Withdrawn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)

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, 6 Oct 2026

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

The TrailBlazer Angled Support Catheter is a percutaneous, single lumen catheter designed for use in the peripheral vascular system. It is intended to guide and support a guide wire during access of the vasculature, facilitate guide wire exchanges, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

This device is supplied as a single lumen catheter and is authorized under FDA 510(k) clearance K162384. It is designed for use in peripheral vascular procedures to assist in navigation and fluid delivery.