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Implantable Pacing Lead Tined #3390

FDA 510(k)

Class III (US FDA 510(k))

510(k) K823448

by Oscor Inc.

Identifiers

510(k) Number
K823448 FDA 510(k)
FDA Product Code
DTB FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It is designed for implantation within the heart to deliver electrical pacing stimuli, ensuring proper cardiac rhythm and function in patients requiring cardiac pacing support. The tined design enhances fixation within cardiac tissue, providing stable lead positioning for long-term use.

The Implantable Pacing Lead Tined #3390 is supplied sterile and intended for single-use implantation by qualified healthcare professionals. It is regulated under FDA 510(k) clearance (K823448) and falls under the decision code SESE (Substantially Equivalent) classification, with advisory committee oversight from the Cardiovascular panel. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.

Frequently asked questions

What is the primary purpose of the IMPLANTABLE PACING LEAD TINED #3390, and how does its design support long-term use in patients?

The IMPLANTABLE PACING LEAD TINED #3390 is designed to deliver electrical pacing stimuli within the heart to maintain proper cardiac rhythm for patients requiring cardiac pacing support. Its tined design enhances fixation within cardiac tissue, ensuring stable lead positioning and reducing the risk of displacement over time. This design is particularly beneficial for long-term use, as it helps maintain consistent pacing functionality without frequent repositioning.

Is this device intended for single-use or reusable applications, and what are the storage requirements to maintain sterility?

The IMPLANTABLE PACING LEAD TINED #3390 is sterile and intended for single-use only, meaning it should not be reused after implantation. To preserve sterility before use, it must be stored and handled according to sterile medical device protocols, such as those outlined for implantable devices. Proper storage conditions—typically in a sealed, sterile packaging—are critical to prevent contamination prior to implantation by qualified healthcare professionals.

What regulatory pathway does this device follow, and which advisory committee oversees its classification?

This device follows the FDA 510(k) clearance pathway, specifically under the Traditional route, with a classification of Substantially Equivalent (SESE). Its regulatory oversight is handled by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under FDA regulations. The clearance number is K823448, and the decision was made on December 3, 1982.

Are there multiple sizes or models of this lead, and if so, how are they differentiated?

The provided data does not specify distinct sizes or models beyond the IMPLANTABLE PACING LEAD TINED #3390 designation. However, the OpenFDA registration numbers (e.g., 3002618605, 2017865) suggest multiple FEI (Facility Establishment Identifier) registrations, which may correlate to variations in manufacturing lots or slight design iterations. For precise sizing or model differentiation, refer to the manufacturer’s technical documentation or catalog, as the data does not detail these distinctions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Oscor Inc.
FDA Applicant
Oscor, Inc.

Sources (1)

  • FDA 510(k) K823448 24 fields · synced Sep 18, 2026