Models 1025M & 1026T Pacing Lead
by Pacesetter Systems 510(k)
Active
510(k) K873931
Overview
This device is a Permanent Pacemaker Electrode, designed to deliver electrical stimulation to the heart for pacing purposes. It facilitates cardiac rhythm regulation by transmitting low-energy pulses to the myocardium, ensuring proper heart function in patients with bradycardia or conduction disorders.
The Models 1025M & 1026T Pacing Lead are supplied as single-use electrodes, intended for implantation in cardiac settings. They are classified as Class III devices under FDA regulations and were granted Traditional 510(k) clearance through the Cardiovascular Advisory Committee. Sterility and proper handling are critical for implantation, and their use is governed by FDA authorization (K873931)
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873931 | Date22 Oct 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Modified Models 1025M & 1026T Pacing Lead
- 510(k) Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
Are these pacing leads designed for single-use or can they be reused after implantation?
These leads (Models 1025M & 1026T) are explicitly supplied as single-use electrodes for implantation. Reuse is not recommended or authorized, as sterility and proper handling are critical for safe cardiac pacing. The device description and FDA clearance (K873931) emphasize their intended use in sterile, one-time implantation procedures.
What types of patients are these pacing leads intended to support, and how do they function?
These leads are designed for patients with bradycardia or conduction disorders requiring cardiac rhythm regulation. They deliver low-energy electrical pulses to the myocardium via the myocardium to maintain proper heart function. The device description specifies their role as a permanent pacemaker electrode, ensuring reliable pacing stimulation in clinical settings.
How are these leads supplied, and what should clinicians verify before use?
The leads are supplied as sterile, single-use electrodes ready for implantation. Clinicians should verify sterility and proper handling per FDA guidelines, as the device is classified as Class III and governed by clearance K873931. The packaging and storage conditions must align with sterile medical device protocols to prevent contamination before use.
What regulatory pathway was followed for FDA clearance of these pacing leads?
The Models 1025M & 1026T underwent a Traditional 510(k) review through the Cardiovascular Advisory Committee (CV). The clearance (K873931) was granted in 1987, with a decision of Substantially Equivalent (SESE) to predicate devices. The submission was filed under product code DTB and categorized under regulation number 870.3680.
Are there multiple sizes or models available for these pacing leads, and how are they differentiated?
Yes, these leads include two distinct models: 1025M and 1026T. While the data does not specify exact size variations, the differentiation likely lies in design or functional features (e.g., electrode configuration or pacing capabilities). The openFDA registration numbers list multiple lot-specific identifiers, but the core distinction between the two models is not detailed beyond their classification as modified permanent pacemaker electrodes.