Models 1113 and 1114 Pacemaker Leads

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K893763 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Possis Medical, Inc. →

• What are the primary clinical uses for these pacemaker leads, and how do they function in the body?

  These Models 1113 and 1114 Pacemaker Leads are designed to treat patients with bradycardia (slow heart rate) or conduction disorders, delivering electrical impulses to stimulate the heart muscle and maintain proper cardiac rhythm. Implanted within the heart, they connect to an external pacemaker to ensure synchronized contractions, helping restore normal heart function.

• Are these leads intended for single-use or reusable applications, and how are they supplied?

  The leads are sterile and intended for single-use only, meaning each lead is meant to be implanted once and then discarded. They are supplied pre-sterilized, ready for immediate use in cardiac electrophysiology procedures without requiring additional sterilization.

• What storage conditions should be followed for these pacemaker leads before implantation?

  While specific storage instructions aren’t detailed in the provided data, as sterile, single-use medical devices, these leads should be stored in their original packaging in a clean, dry environment away from direct sunlight, extreme temperatures, and contaminants. Always follow the manufacturer’s printed instructions for optimal shelf life and sterility.

• Are there any restrictions on using these leads with MRI procedures, and why?

  The data does not specify MRI safety restrictions for these leads, meaning they may or may not be MRI-compatible depending on the specific model and settings. However, since they are permanent pacemaker electrodes, it’s critical to verify compatibility with your MRI system and consult the manufacturer’s guidelines before use to avoid potential risks to the patient.