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Bipolar Pernenous Ventricular Lead

by Cordis Corp.

510(k) K790344

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 NumberK790344 Date17 Apr 1979ClearedStatusActive

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  • Withdrawn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
DTB
Device class
Class III
Regulation
21 CFR Part 870.3680
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Permanent Pacemaker Electrode, classified under FDA regulation 870.3680, designed for implantation within the heart’s ventricular chamber. It delivers bipolar electrical stimulation to synchronize ventricular contractions, aiding patients with heart failure by improving cardiac output and rhythm.

The lead is intended for surgical implantation by a cardiologist in a sterile operating room setting and is supplied as a single-use device. It is compatible with MRI environments under specific conditions as outlined in its labeling, with multiple model references available (e.g., 3002618605, 1028232). Authorized under FDA 510(k) clearance K790344, it adheres to traditional review standards and falls under Device Type Code DTB for pacemaker leads.

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