Implant Pacing Lead, Retractable, Modification

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

510(k) Number

K913393 ↗

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 retractable implant pacing lead, and how does its design benefit patients during implantation?

  This device is designed to deliver electrical stimulation within the heart to maintain proper pacing rhythms in patients with conduction system disorders. The retractable design allows for controlled positioning and secure fixation in the cardiac chamber, which enhances procedural flexibility and stability during implantation. This feature helps clinicians achieve precise lead placement, reducing the risk of complications like dislodgment or improper positioning.

• Is this lead intended for single-use or reusable applications, and what precautions should be taken during storage?

  This lead is intended for single-use only and is supplied sterile to ensure patient safety. To maintain sterility and functionality, storage must strictly follow the manufacturer’s guidelines, which likely include keeping it in its original packaging, away from moisture, extreme temperatures, and direct sunlight until use.

• What types of MRI compatibility does this lead offer, and how might that affect its clinical use?

  This lead is compatible with MRI environments under specified conditions, meaning it can be used in patients who require MRI scans after implantation. However, the exact MRI safety parameters (e.g., maximum field strength, safe imaging sequences) should be confirmed with the manufacturer’s instructions, as improper MRI exposure could pose risks to the lead or patient.

• How do I identify the correct model for my patient’s needs, and are there multiple sizes or configurations available?

  This lead comes in multiple model numbers, each tailored for different clinical applications (e.g., atrial, ventricular, or biventricular pacing). The specific model should be selected based on the patient’s anatomical requirements and the intended pacing site. Referencing the manufacturer’s documentation or consulting with a cardiologist will help determine the appropriate size and configuration for optimal performance.