Oscor Medical Unipolar Permanent Pacing Lead-Conne

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

510(k) Number

K854128 ↗

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. →

• What is the primary purpose of this unipolar permanent pacing lead, and where is it implanted within the body?

  This device is designed to deliver electrical impulses to the heart muscle to regulate abnormal heart rhythms, such as arrhythmias or conduction disorders. It is intended for endocardial or epicardial implantation, meaning it can be placed either inside the heart chamber (endocardial) or on the outer surface of the heart (epicardial) and connects to an implanted pacemaker system for continuous pacing support.

• Is this lead reusable, or is it meant for single-use only? How should it be handled to maintain sterility?

  The lead is sterile and intended for single-use only after implantation. Since it is classified as a sterile medical device, it must be handled using aseptic techniques to prevent contamination. Storage should follow sterile medical device protocols to ensure integrity until use.

• What configurations are available for this pacing lead, and how does this affect its use?

  This lead is available in two configurations: a straight design or a preformed J-shaped design. The J-shaped lead may offer advantages in positioning within the heart, particularly for epicardial applications, while the straight lead may provide flexibility for endocardial placement depending on anatomical needs.

• What type of connector system is compatible with this lead, and how does that impact its use with pacemakers?

  The lead is compatible with IS-1 connector systems, which are standard for permanent pacemaker leads. This ensures compatibility with most modern pacemaker systems, allowing for secure electrical connection between the lead and the implanted pacemaker device.

• How was this device’s regulatory pathway determined, and what does that mean for its use in clinical settings?

  The lead was cleared through the FDA’s 510(k) Traditional Review pathway under product code DTB (Permanent Pacemaker Electrode) and is classified as a Class III device (regulation 870.3680). This means it underwent a thorough review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness for its intended use in regulating abnormal heart rhythms via permanent pacing.