Modified Oscor Py Pacing Leads/Modification

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

510(k) Number

K913158 ↗

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

• Model Py...u Unipolar & Bipolar Pacing Lead

  Class III

  FDA 510(k) K870034 Active Cleared 3 Mar 1987

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

  Class II

  FDA 510(k) K850622 Active Cleared 10 Apr 1985

See all devices from Oscor Medical Corp. →

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

  These Modified Oscor PY Pacing Leads are explicitly intended for single-use only and are supplied sterile for direct implantation. The device description and FDA 510K submission emphasize their sterile packaging and intended use in a single cardiac procedure to ensure patient safety and compliance with medical device standards.

• What types of pacemaker systems are these leads compatible with, and how do I determine the correct model for my patient?

  These leads are designed for compatibility with various pacemaker systems, as indicated by the multiple OpenFDA reference codes (e.g., 3002618605, 1028232, etc.). To select the correct model, verify the specific lead specifications (e.g., electrode type, coil configuration, or connector size) against your pacemaker system’s requirements. The manufacturer’s documentation or a clinical specialist can assist in matching the right lead to your patient’s device.

• How should these leads be stored before use, and what precautions should be taken to maintain sterility?

  Since these leads are sterile upon packaging, they must be stored in their original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by ensuring the sterile barrier is intact until immediate pre-procedure preparation. Always follow the manufacturer’s storage guidelines to prevent degradation or compromise of sterility.

• What regulatory pathway was followed for FDA clearance of these leads, and what does that mean for clinical use?

  These leads were cleared through the FDA 510K pathway (K913158), specifically under the Traditional review process with a Substantially Equivalent (SESE) determination. This means the device was compared to a legally marketed predicate and deemed equivalent in safety and effectiveness for its intended use as a permanent pacemaker electrode. Clinically, this clearance confirms the leads meet FDA standards for cardiac pacing applications, but always verify compatibility with your facility’s protocols and the specific pacemaker system in use.