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Temp. Pervenous Lead W/Remote Anode

by Cordis Corp.

510(k) K770214

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 NumberK770214 Date28 Mar 1977ClearedStatusActive

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  • Withdrawn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 as a Class III medical device under FDA regulations. It is designed for temporary transvenous placement to facilitate cardiac pacing, delivering electrical impulses to regulate heart rhythm in patients requiring short-term pacing support. The lead incorporates a remote anode to enhance pacing efficiency and reduce discomfort for the patient.

The Temporary Percutaneous Lead with Remote Anode is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K770214) and falls under the Permanent Pacemaker Electrode category (DTB, regulation number 870.3680). Compatible with MRI environments as indicated by its design specifications, it is distributed in sterile packaging for immediate clinical use. No reusable components are specified.

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