3.2MM Unipolar & Bipolar Lead Connectors (VS-1)

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

510(k) Number

K862966 ↗

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 the 3.2mm Unipolar & Bipolar Lead Connectors (VS-1) in cardiac procedures?

  These connectors are designed to establish a secure electrical connection between cardiac leads and implantable pacemakers or defibrillators. They ensure stable signal transmission for reliable pacing or defibrillation therapy, supporting both unipolar and bipolar lead configurations in cardiac electrophysiology procedures.

• Are the 3.2mm Unipolar & Bipolar Lead Connectors (VS-1) intended for reuse, or are they single-use devices?

  The connectors are explicitly supplied as sterile, single-use devices. They must be handled in a controlled clinical environment to maintain sterility and prevent contamination, ensuring safe and reliable use in each procedure.

• What storage conditions are required to maintain the integrity of the 3.2mm Unipolar & Bipolar Lead Connectors (VS-1)?

  To preserve their functionality, these connectors must be stored protected from moisture and contamination. Proper storage conditions are critical to maintaining their sterility and performance before use in cardiac electrophysiology procedures.

• What diameter standardizes compatibility with lead systems for the 3.2mm Unipolar & Bipolar Lead Connectors (VS-1)?

  The connectors feature a 3.2mm diameter, which standardizes compatibility with compatible lead systems, ensuring a secure and reliable connection for pacing or defibrillation therapy.

• How is the regulatory status of the 3.2mm Unipolar & Bipolar Lead Connectors (VS-1) determined?

  The device holds FDA 510(k) clearance (K862966) and is classified under 21 CFR 870.3680 for permanent pacemaker electrodes. The clearance was granted through a traditional 510(k) review process by the FDA’s Cardiovascular (CV) Advisory Committee, confirming its substantial equivalence to a predicate device.