Cardifix EZ Bipolar/Unipolar Endocardial Pacing Lead
510(k) K955550
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)ST | NumberK955550 | Date19 Jun 1996 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- ST
Overview
AI-generated summary, 18 Sep 2026
The Cardifix EZ Bipolar/Unipolar Endocardial Pacing Lead is a permanent pacemaker electrode designed for endocardial pacing. It delivers electrical stimulation to the heart’s inner lining to regulate cardiac rhythm in patients requiring chronic pacing support, available in both bipolar and unipolar configurations for compatibility with various pacemaker systems.
This lead is intended for surgical implantation via the venous system into the right atrium or ventricle, adhering to the endocardium for stable pacing. Supplied sterile and intended for single-use, it is classified as a Class III device under FDA regulations and has received 510(k) clearance as substantially equivalent with traditional review. Multiple reference codes (e.g., K955550) and regulatory identifiers (e.g., DTB product code) further define its compliance and tracking requirements.