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Implantable Pacing Lead, Tined #3262

by Vascular Products, Inc.

510(k) K823447

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 NumberK823447 Date3 Dec 1982ClearedStatusActive

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  • Withdrawn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 an Implantable Pacing Lead, Tined, classified as a Permanent Pacemaker Electrode under regulatory nomenclature. It is designed for use in cardiac pacing systems to deliver electrical impulses to the heart, facilitating proper heart rhythm regulation in patients requiring chronic pacing support.

The lead is intended for implantable use within the cardiovascular system and is supplied sterile for single-use implantation. It adheres to FDA 510(k) clearance under the Traditional pathway (K823447) and falls under Device Class III (regulation 870.3680). Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.

Other devices from Vascular Products, Inc.

Questions

AI-generated answers, 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.

  • What is the primary use of this implantable pacing lead, and how does it function within a cardiac pacing system?

    This device is designed as a permanent pacemaker electrode for use in cardiac pacing systems. It delivers electrical impulses to the heart to help regulate and maintain proper heart rhythm in patients who require chronic pacing support. The tined design ensures secure anchoring within the cardiovascular system, allowing reliable stimulation of the heart muscle.

  • Is this lead intended for single-use or reusable applications, and what are the storage requirements?

    The lead is sterile and intended for single-use only after implantation. Since it is a sterile medical device, storage must follow strict sterile protocols to preserve its integrity before use. Improper handling could compromise sterility and patient safety.

  • How is this device regulated, and what pathway was used for FDA clearance?

    This lead is classified under FDA 510(k) clearance as a Permanent Pacemaker Electrode, falling under Device Class III (regulation 870.3680). It was cleared via the Traditional pathway (K823447) and is considered substantially equivalent to prior devices. The review was conducted by the Cardiovascular (CV) Advisory Committee.

  • What types of patients or clinical settings would this lead be relevant for?

    While the exact clinical indications are not specified, this lead is designed for patients requiring chronic cardiac pacing support, such as those with bradycardia, heart block, or other conditions necessitating long-term electrical stimulation of the heart. It is intended for implantable use within the cardiovascular system as part of a pacing system.