Pacepath Implant. Endocard. Pacing Lead
by Pacesetter Systems 510(k)
Active
510(k) K810286
Overview
The Pacemapth Implant Endocardial Pacing Lead is a permanent pacemaker electrode designed for endocardial pacing. This device delivers electrical impulses to stimulate the heart muscle, ensuring proper cardiac rhythm by positioning its electrodes directly within the endocardium, the inner lining of the heart chambers. It is intended for use in patients requiring chronic cardiac pacing to manage bradycardia or other conduction disorders.
This lead is supplied sterile and intended for single-use implantation via a venous approach, typically under fluoroscopic guidance. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and has been granted FDA 510(k) clearance as substantially equivalent to predicate devices. Compatible with standard pacemaker systems, it requires sterile handling and proper surgical techniques for implantation, with no noted MRI safety restrictions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810286 | Date27 Nov 1981 | 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- Withdrawn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 Pacesetter Systems
Questions
What types of patients is this pacing lead designed for, and how is it implanted?
This lead is designed for patients requiring chronic cardiac pacing to manage bradycardia or conduction disorders. It is implanted via a venous approach, typically under fluoroscopic guidance, and is positioned directly within the endocardium—the inner lining of the heart chambers—to deliver electrical impulses for proper cardiac rhythm. It is intended for single-use and requires sterile handling during implantation.
Is this device compatible with standard pacemaker systems, and are there any special handling requirements?
Yes, this lead is compatible with standard pacemaker systems. Due to its sterile packaging and single-use nature, it requires sterile handling and proper surgical techniques during implantation. No MRI safety restrictions are noted for this device.
How is the Pacemapth Implant Endocardial Pacing Lead supplied, and what should I consider for storage?
The lead is supplied sterile and intended for single-use only. Since it is designed for implantation, storage should follow standard sterile medical device protocols—keep it in its original packaging, protected from moisture, and away from extreme temperatures until ready for use.
What regulatory pathway was followed for this device’s approval, and which committee reviewed it?
This device received FDA 510(k) clearance under the traditional review pathway, determined to be substantially equivalent to predicate devices. The review was conducted by the Cardiovascular (CV) Advisory Committee, as indicated by the product code (DTB) and regulatory classification (Class III).