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Permanent Pacing Lead W/Polaris Coated Tips, Various Models

FDA 510(k)

Class III (US FDA 510(k))

510(k) K013339

by Oscor Inc.

Identifiers

510(k) Number
K013339 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
ST FDA 510(k)

This device is a Permanent Pacemaker Electrode, classified under FDA regulation 870.3680, designed for implantation in cardiac pacing systems. It delivers electrical impulses to regulate heart rhythm by stimulating the heart muscle, ensuring proper cardiac function for patients requiring chronic pacing support. The lead features Polaris coated tips, which enhance electrical conductivity and minimize tissue inflammation at the implantation site.

The lead is supplied sterile and intended for single-use implantation, though specific models may vary in design and compatibility with pacemaker systems. It is regulated under FDA 510(k) clearance (K013339) with a Special Substantially Equivalent determination, subject to tracking under the Cardiovascular advisory committee. Various models are listed under OpenFDA registration numbers, including 3002618605, 3008377825, and others, ensuring traceability and compliance with Class III medical device standards.

Frequently asked questions

What is the primary purpose of the Polaris coating on these pacing leads, and how does it benefit patients?

The Polaris coating on these permanent pacing leads enhances electrical conductivity, ensuring more efficient stimulation of the heart muscle. It also minimizes tissue inflammation at the implantation site, which can reduce complications like fibrosis or lead displacement over time. This helps maintain long-term pacing reliability and patient comfort.

Are these leads reusable, or are they intended for single-use only? How does this affect clinical workflow?

These leads are intended for single-use only, as explicitly stated in the device description. This design choice aligns with sterile implantation requirements and reduces infection risks. Clinically, this means each lead must be opened and used immediately post-sterilization packaging, requiring proper inventory management to avoid waste or reuse.

How do I verify the compatibility of these leads with my existing pacemaker systems?

Compatibility depends on the specific model, as the device description notes that various models are available. While the exact models aren’t listed in clinical terms, the OpenFDA registration numbers (e.g., 3002618605, 3008377825) can be cross-referenced with your pacemaker manufacturer’s documentation or technical support. Always confirm with the manufacturer to ensure electrical and mechanical compatibility before implantation.

What storage conditions are recommended for these leads to maintain sterility and performance?

Since the leads are supplied sterile, they should be stored in their original, unopened packaging to preserve sterility. The packaging is designed to protect against contamination, but exposure to extreme temperatures, moisture, or direct sunlight should be avoided. Check the manufacturer’s instructions for the specific shelf-life post-manufacture, as this may vary by model.

What does the “Special Substantially Equivalent” determination mean for these leads, and how does it affect their use?

The ‘Special Substantially Equivalent’ (ST) determination under FDA 510(k) clearance (K013339) indicates that while these leads share the same intended use as a predicate device, they may have unique features or design changes that required additional scrutiny. Clinically, this means the device has undergone rigorous review for safety and effectiveness, but it also subjects these leads to tracking under the Cardiovascular advisory committee, ensuring post-market surveillance. No additional clinical restrictions apply beyond standard implantation protocols.

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. Sources consulted: Permanent Pacing Lead W/Polaris Coated Tips, Various Models, PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS 510 (k ..., permanent pacing lead w polaris coated tips various models

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) K013339 24 fields · synced Sep 18, 2026