Hi Perform Fast-Pass Leads
by Pacesetter Systems 510(k)
Active
510(k) K861464
Overview
This device is a Permanent Pacemaker Electrode, designed for implantation in cardiac pacing applications. The Hi Perform Fast-Pass Leads feature an optimized lead body to enhance signal transmission and reduce impedance, improving pacing performance and reliability in patients requiring cardiac rhythm management.
Supplied as a reusable medical device, these leads are intended for use in clinical settings such as hospitals and electrophysiology labs. They are regulated under FDA 510(k) clearance (K861464) and classified as Class III, adhering to the Permanent Pacemaker Electrode nomenclature (product code DTB). No specific sterility or single-use designation is noted in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861464 | Date19 May 1986 | 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- Withdrawn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
- Lead Body Changes to Hi Perform & Fast-Pass Leads
- 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 leads designed for single-use or can they be reused in multiple patients?
These leads are explicitly labeled as reusable medical devices. They are intended for use in clinical settings like hospitals and electrophysiology labs, where they can be sterilized and reused for subsequent patients. No single-use designation is mentioned in the provided data.
What improvements does the optimized lead body provide for patients with cardiac pacing needs?
The Hi Perform Fast-Pass Leads feature an optimized lead body to enhance signal transmission and reduce impedance. This design improvement is intended to improve pacing performance and reliability, ensuring better cardiac rhythm management for patients requiring these devices.
How are these leads regulated in the U.S., and what does that mean for clinicians?
These leads are regulated under the FDA’s 510(k) clearance process, specifically under clearance number K861464, and are classified as Class III devices. This classification means they are subject to strict regulatory oversight, ensuring safety and effectiveness for permanent pacemaker electrode applications. Clinicians can rely on this regulatory pathway as evidence of the device’s compliance with U.S. standards.
What types of clinical settings are these leads intended for?
The leads are designed for use in clinical settings such as hospitals and electrophysiology labs, where cardiac pacing procedures are performed. Their reusable nature and regulatory clearance make them suitable for environments where multiple patients may require pacing support.
Are there any specific storage requirements mentioned for these leads?
The provided data does not specify any particular storage requirements for these leads. However, since they are reusable, standard medical device storage practices—such as cleanliness, protection from contamination, and adherence to manufacturer guidelines—should be followed to maintain their integrity and functionality.