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Model 1300 Softrace II Electrode

by Medtronic Vascular

510(k) K921164

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921164 Date18 Mar 1993ClearedStatusActive

Official records

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  • Withdrawn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
DRX
Device class
Class II
Regulation
21 CFR Part 870.2360
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Model 1300 Softrace II Electrode is a cardiovascular diagnostic device classified under product code DRX. It is designed as a reusable electrode intended for use in electrophysiological studies and mapping procedures, facilitating precise cardiac signal detection and recording during diagnostic evaluations.

This electrode is supplied sterile and intended for single-use applications in clinical settings. It adheres to FDA 510(k) clearance (K921164) under the Cardiovascular (CV) advisory committee, with a decision date of March 18, 1993. The device is regulated under the classification of FDA Class II and is intended for use in electrophysiological procedures, though no MRI safety or additional size specifications are noted in the available data.

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