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Implant Pacing Lead Tined #3390, Modification

by Oscor Medical Corp.

510(k) K913203

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 NumberK913203 Date23 Sep 1991ClearedStatusActive

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  • Withdrawn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
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 regulation 870.3680. It is designed as an implantable lead used in cardiac pacing systems to transmit electrical impulses from an implanted pacemaker to the heart muscle, maintaining proper cardiac rhythm.

The Implant Pacing Lead Tined #3390 is intended for single-use implantation in cardiovascular procedures. It is supplied sterile and requires surgical implantation by a qualified healthcare professional. The device is regulated under FDA 510(k) clearance (K913203) and falls under the DTB product code, with a decision of Substantially Equivalent (SESE) granted in 1991.

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