Modified Oscor Py Pacing Leads

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

510(k) Number

K862330 ↗

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 intended for single-use or can they be reused after implantation?

  The Modified Oscor Py Pacing Leads are explicitly classified as reusable medical devices in the regulatory filing. This means they are designed for repeated use in patients after proper cleaning, sterilization (if applicable), and maintenance procedures. Since they are regulated under FDA 510(k) clearance, their reuse status is confirmed through the regulatory submission process, though specific sterilization or cleaning instructions are not detailed in the provided data.

• What types of arrhythmias or cardiac conditions are these leads primarily used to manage?

  These leads are permanent pacemaker electrodes intended for transvenous insertion within the heart chambers to deliver electrical stimulation. They are used in patients with arrhythmias or bradycardia to ensure proper cardiac rhythm management by transmitting impulses from an implanted or external pacemaker. The regulatory filing specifies their use in cardiovascular applications, but the exact arrhythmias or conditions are not listed beyond general pacing needs.

• How are these leads supplied, and what sizes or models are available?

  The data provided does not specify exact sizes or model variations, but the Modified Oscor Py Pacing Leads are supplied as reusable devices for permanent pacemaker use. The regulatory filing lists multiple FEI numbers (e.g., 3002618605, 1028232), which may correspond to different lead configurations or variants, though no detailed specifications (e.g., length, diameter, or electrode type) are included. For precise sizing or model details, manufacturer documentation or direct inquiry to Oscor Medical Corp. would be necessary.

• What is the regulatory pathway for these leads, and how were they cleared by the FDA?

  The Modified Oscor Py Pacing Leads were cleared through the FDA 510(k) process under Traditional Review, with a decision of Substantially Equivalent (SESE) to a predicate device. The filing date was June 19, 1986, and clearance was granted on August 8, 1986, with the product code DTB (Permanent Pacemaker Electrodes). The Cardiovascular (CV) Advisory Committee reviewed the submission, confirming their use in cardiovascular applications for pacing purposes.

• Are there any specific storage requirements mentioned for these reusable leads?

  The provided data does not include explicit storage instructions for the Modified Oscor Py Pacing Leads. Since they are reusable, proper handling and storage (e.g., clean, dry environment, protection from contamination) would typically be required to maintain sterility and functionality. For detailed storage guidelines, refer to the manufacturer’s instructions or technical documentation from Oscor Medical Corp., as these are not specified in the regulatory filing.