Model Py...u Unipolar & Bipolar Pacing Lead

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K870034 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Implant Pacing Lead Tined #3390, Modification

  Class III

  FDA 510(k) K913203 Active Cleared 23 Sep 1991

• Miscellaneous Pacing Lead

  Class II

  FDA 510(k) K925168 Active Cleared 3 May 1994

• Pacer Sensing Analyzer (Psa 100)

  Class II

  FDA 510(k) K882327 Active Cleared 6 Oct 1988

• Implant Pacemaker Lead, Tined

  Class III

  FDA 510(k) K913201 Active Cleared 23 Sep 1991

• Oscor Medical Model Tme 64S Bipolar Temp/Heart Wir

  Class II

  FDA 510(k) K850622 Active Cleared 10 Apr 1985

• Implant Pacing Lead, Tined #3262, Modification

  Class III

  FDA 510(k) K913202 Active Cleared 23 Sep 1991

See all devices from Oscor Medical Corp. →

• What types of pacing configurations does the Model PY...U Pacing Lead support, and how does this affect its use in patients?

  The Model PY...U Pacing Lead is available in both unipolar and bipolar configurations, allowing clinicians to choose based on patient needs and pacing requirements. The unipolar design delivers electrical impulses through a single electrode, while the bipolar configuration uses two electrodes to provide more precise pacing control and potentially reduce pacing thresholds. This versatility enables tailored pacing therapy for patients with arrhythmias requiring either endocardial or epicardial implantation.

• Is this device intended for reuse, or is it meant to be used only once after opening? How should it be handled to maintain sterility?

  This device is supplied sterile and explicitly intended for single-use only. It must remain in its sterile packaging until implantation and should not be reused. Sterility must be preserved by following standard sterile medical device protocols, including proper handling, storage, and surgical implantation by a healthcare professional to avoid contamination.

• What regulatory pathway was followed for this device, and what does that mean for its use in clinical practice?

  The Model PY...U Pacing Lead was authorized through the FDA 510(k) clearance process (K870034), specifically under the Cardiovascular (CV) advisory committee, and classified as a Class III medical device. This means it underwent a review to demonstrate substantial equivalence to a predicate device and adheres to 21 CFR 870.3680 for permanent pacemaker electrodes. Clinically, this ensures it meets FDA standards for safety and effectiveness in regulating heart rhythm for patients with arrhythmias.

• Can this lead be implanted in both the heart’s inner lining (endocardium) and outer surface (epicardium)? How does that impact its design?

  Yes, the Model PY...U Pacing Lead is intended for both endocardial and epicardial implantation, meaning it can be placed either inside the heart chambers or on the outer heart surface. This dual-use design allows clinicians to select the optimal approach based on patient anatomy, procedure complexity, or specific clinical needs (e.g., congenital heart defects or post-cardiac surgery scenarios). The lead’s construction supports both applications while maintaining reliable electrical conduction.

• What storage requirements should be followed to ensure the device remains effective and sterile until use?

  Since the device is sterile and single-use, it must be stored in its original, unopened packaging in a clean, dry environment protected from physical damage, moisture, and extreme temperatures. Adherence to sterile medical device protocols—such as avoiding contamination during handling and ensuring the packaging integrity—is critical. Improper storage could compromise sterility or functionality before implantation.