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Permanent Pacing Lead (Petite +7 more)

FDA 510(k)

Class III (US FDA 510(k))

510(k) K020669

by Oscor Inc.

Identifiers

510(k) Number
K020669 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
Petite FDA 510(k)
Petite R FDA 510(k)
J FDA 510(k)
Rj FDA 510(k)
Petite B FDA 510(k)
Rb FDA 510(k)
Jb FDA 510(k)
Rjb 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 under 21 CFR 870.3680, designed for implantation in the cardiovascular system. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other pacing indications, ensuring consistent cardiac function through chronic stimulation of the heart muscle.

The leads are intended for single-use implantation during cardiac procedures, supplied sterile and packaged for surgical use. They are regulated under FDA 510(k) clearance (K020669) as substantially equivalent to predicate devices, adhering to Class III medical device standards. Each model (Petite, Petite R, J, RJ, Petite B, RB, JB, RJB) may vary in electrode configuration or fixation mechanism but shares the same core function and regulatory classification.

Frequently asked questions

Are these pacing leads designed for reuse in multiple patients, or are they intended for single-use only?

These permanent pacing leads are explicitly designed for single-use implantation during cardiac procedures. They are supplied sterile and packaged for surgical use, ensuring compliance with medical device sterility standards for one-time patient use.

What distinguishes the different models (e.g., Petite, Petite R, J, RJ) in terms of their clinical application?

The models vary primarily in electrode configuration or fixation mechanism, which may influence how they anchor within the heart or deliver electrical impulses. For example, some may feature tines (e.g., 'J' or 'JB' variants) for active fixation, while others may rely on passive fixation (e.g., 'Petite' or 'Petite R'). The exact differences are detailed in the manufacturer’s technical documentation, but all share the core function of chronic cardiac pacing.

How should these leads be stored before use, and what precautions should be taken?

Since these leads are sterile and packaged for surgical use, they must be stored in their original, unopened packaging to maintain sterility. The packaging should be kept in a clean, dry environment, protected from extreme temperatures, moisture, or physical damage. Always follow the manufacturer’s instructions for expiration dates and handling to ensure device integrity.

What regulatory pathway was followed for FDA clearance of these pacing leads, and what does that mean for clinicians?

These leads were cleared via the FDA 510(k) pathway, specifically under Special 510(k) review by the Cardiovascular (CV) Advisory Committee. The clearance (K020669) confirms they are substantially equivalent to predicate devices, meaning they meet Class III medical device standards for safety and effectiveness. Clinicians can rely on this pathway as evidence of rigorous review, though individual patient selection and implantation should still follow established clinical guidelines.

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, Models Petite, Petite R, J, Rj, Petite B, Rb, Jb ..., PDF Permanent Pacing Lead, Models Petite, Petite R, J, Rj, Petite B, Rb, Jb ..., PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J… - FDA.report

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) K020669 24 fields · synced Oct 6, 2026