Encor Pervenous J-Atrial Leads
510(k) K873772
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873772 | Date19 Oct 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Changes to Encor Pervenous J-Atrial 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
Overview
AI-generated summary, 18 Sep 2026
The Encor Pervenous J-Atrial Leads are classified as Permanent Pacemaker Electrodes, designed for implantation in the right atrium of the heart. These leads are intended for use in cardiac pacing systems to deliver electrical stimulation, ensuring proper heart rhythm and function in patients with bradycardia or other conduction disorders.
These leads are supplied sterile and intended for single-use implantation during cardiac procedures. They are regulated under FDA 510(k) clearance (K873772) and fall under the classification of Class III medical devices (device class 3). The leads are compatible with MRI environments under specific conditions, as outlined in their technical specifications, and are distributed in various sizes and configurations as indicated by the registration numbers.
Other devices from Cordis Leads, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these leads reusable, or are they intended for single-use only during implantation?
The Encor Pervenous J-Atrial Leads are explicitly supplied sterile and intended for single-use implantation during cardiac procedures. This ensures patient safety and compliance with sterile field requirements during surgery.
What sizes or configurations are available for these leads, and how do I identify them?
These leads come in multiple sizes and configurations, each associated with a unique registration number (e.g., 3002618605, 1028232, etc.). The list of available models is included in the provided registration numbers under the `openfda` field, which can help identify the correct variant for your procedure.
Can these leads be used in patients who require MRI scans, and if so, what conditions apply?
The Encor Pervenous J-Atrial Leads are compatible with MRI environments under specific conditions, as detailed in their technical specifications. However, the exact parameters (e.g., MRI strength, safety protocols) must be reviewed in the device’s labeling or manufacturer documentation to ensure proper use.
How are these leads distributed, and what should I consider when storing them?
These leads are supplied sterile and packaged for single-use. Storage should follow standard sterile medical device protocols—keep them in a clean, dry environment, protected from contamination, and adhere to the manufacturer’s expiration or shelf-life guidelines to maintain integrity.
What regulatory pathway was followed for these leads, and which advisory committee was involved?
The Encor Pervenous J-Atrial Leads underwent FDA 510(k) clearance (K873772) under the Cardiovascular (CV) Advisory Committee, with a decision dated October 19, 1988. The submission was classified as substantially equivalent (SESE) and falls under Class III medical devices, reflecting their critical role in cardiac pacing.