Skip to content

Permanent Pacing Leads, Modification

by Oscor Medical Corp.

510(k) K915007

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 NumberK915007 Date27 Jan 1992ClearedStatusActive

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  • Withdrawn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, designed for implantation in cardiac pacing procedures. It serves as an interface between a pacemaker generator and the heart muscle, facilitating electrical stimulation to regulate heart rhythm in patients with bradycardia or conduction system disorders. The leads are engineered for long-term use within the cardiovascular system, ensuring reliable pacing support.

The leads are supplied sterile and intended for single-use implantation, adhering to FDA 510(k) clearance (K915007) under regulation 870.3680. They are classified as Class III medical devices, requiring strict adherence to manufacturing and quality control standards. Storage and handling must comply with sterile medical device protocols to maintain integrity before use. No additional regulatory status beyond the stated FDA clearance is implied.

Other devices from Oscor Medical Corp.

See all devices from Oscor Medical Corp. →

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 purpose of these permanent pacing leads, and how do they function in the body?

    These permanent pacing leads are designed to serve as the electrical interface between a pacemaker generator and the heart muscle. They facilitate regulated electrical stimulation to maintain proper heart rhythm in patients with bradycardia or conduction system disorders, ensuring long-term pacing support within the cardiovascular system.

  • Are these leads intended for single-use or reusable applications, and what are the storage requirements?

    These leads are intended for single-use implantation only and are supplied sterile. To maintain sterility and integrity before use, they must be stored and handled according to standard sterile medical device protocols, as required for Class III devices.

  • What regulatory pathway was followed for FDA clearance, and which advisory committee was involved?

    The leads underwent a traditional 510(k) clearance process (K915007) under FDA regulation 870.3680, classified as substantially equivalent to a predicate device. The Cardiovascular (CV) Advisory Committee reviewed the submission, which was filed on November 4, 1991, and cleared on January 27, 1992.

  • How do I confirm the correct model or size for my patient’s specific needs?

    The device data lists multiple FEI numbers (e.g., 3002618605, 1028232) and registration numbers, which correspond to different models or variants of these permanent pacing leads. To ensure compatibility, consult your supplier or manufacturer’s documentation to match the lead specifications with your patient’s anatomical and clinical requirements.