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MEDI-TRACE

by Graphic Controls Corp.

510(k) K811410

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 NumberK811410 Date12 Jun 1981ClearedStatusActive

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  • Withdrawn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
KRA
Device Class
Class II
Regulation
21 CFR Part 870.1210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 MEDI-TRACE is a continuous flush catheter used in cardiovascular procedures. It is designed for maintaining patency in vascular access sites.

The device is supplied as a single-use product and is not MRI compatible. It is stored at room temperature and has FDA 510K clearance under product code KRA.

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Questions

AI-generated answers, 26 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 MEDI-TRACE catheter used for?

    The MEDI-TRACE is a continuous flush catheter designed specifically for maintaining patency in vascular access sites during cardiovascular procedures.

  • Is the MEDI-TRACE catheter reusable or single-use?

    The MEDI-TRACE is supplied as a single-use product and should not be reused on multiple patients to ensure patient safety and device performance.

  • What are the storage requirements for the MEDI-TRACE catheter?

    The MEDI-TRACE catheter should be stored at room temperature to maintain its integrity and functionality until use.

  • Is the MEDI-TRACE catheter MRI compatible?

    No, the MEDI-TRACE catheter is not MRI compatible and should not be used in MRI environments.