Pacing Lead Model Bus 860, Bus 890
by R.E. Brown Co., Inc. 510(k)
Active
510(k) K781624
Overview
The Pacing Lead Model Bus 860, Bus 890 is a Permanent Pacemaker Electrode, a medical device designed to deliver electrical impulses to the heart for the treatment of cardiac rhythm disorders. These leads are implanted within the heart to stimulate contractions and maintain proper pacing, ensuring effective cardiac function in patients with bradycardia or other conduction abnormalities.
These leads are intended for single-use implantation in clinical settings such as cardiac catheterization labs or operating rooms. Supplied sterile and packaged for surgical use, they are classified as Class III devices under FDA regulations (870.3680) and have received FDA 510(k) clearance via a traditional review pathway. The Bus 860 and Bus 890 models are compatible with MRI environments under specific conditions, as outlined in their labeling, and require proper storage to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781624 | Date21 Dec 1978 | 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- Withdrawn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
- 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 R.E. Brown Co., Inc.
Questions
Are these pacing leads designed for reuse in multiple patients, or are they intended for single-use only?
These leads (Bus 860 and Bus 890) are explicitly designed for single-use implantation in clinical settings like cardiac catheterization labs or operating rooms. They are supplied sterile and packaged for surgical use, ensuring they meet regulatory standards for one-time patient application.
What storage conditions are required to maintain the sterility and functionality of these leads?
The leads must be stored according to the manufacturer’s instructions to preserve sterility and performance. Since they are supplied sterile and packaged for surgical use, proper storage—typically in a clean, dry environment away from direct sunlight or extreme temperatures—is critical. Always follow the labeling guidelines provided by R.E. Brown Co., Inc., to ensure compliance with regulatory requirements.
Can these leads be used in patients who require MRI scans, and if so, what conditions apply?
Yes, the Bus 860 and Bus 890 models are MRI-compatible under specific conditions, as outlined in their labeling. However, the exact MRI safety parameters (e.g., magnetic field strength, imaging sequences) must be followed to avoid risks like lead displacement or heating. Always verify the manufacturer’s MRI safety documentation before use in an MRI environment.
What types of cardiac rhythm disorders are these leads intended to address?
These leads are designed to deliver electrical impulses to the heart for patients with bradycardia or conduction abnormalities, ensuring proper pacing to maintain effective cardiac function. They are part of a permanent pacemaker system and are not intended for acute or temporary pacing needs.
How do I confirm the regulatory clearance status of these leads before purchasing?
These leads (Bus 860 and Bus 890) have received FDA 510(k) clearance through a traditional review pathway, with the decision code SESE (Substantially Equivalent). The clearance number is K781624, and they fall under product code DTB for Permanent Pacemaker Electrodes. For verification, you can reference the FDA’s openFDA database or contact R.E. Brown Co., Inc. directly for the most up-to-date regulatory documentation.