Implantable Endocardial Porous Tip Electrode
510(k) K801792
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801792 | Date23 Oct 1980 | 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- Withdrawn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
- Implantable Endocardial Porous Tip Elec.
- 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
This device is a Permanent Pacemaker Electrode, classified as an implantable endocardial electrode with a porous tip. It is designed for use in cardiac pacing systems to stimulate the heart muscle, ensuring proper electrical conduction and rhythm regulation in patients with bradycardia or other conduction disorders. The porous tip enhances tissue integration and stability upon implantation.
The electrode is intended for single-use implantation within the cardiac chambers via endocardial access, typically during a surgical procedure. Supplied sterile and packaged for clinical use, it adheres to FDA 510K clearance under the Cardiovascular advisory committee. Compatible with MRI environments under specific conditions (as defined by the manufacturer’s instructions), it is available in multiple model references for compatibility with various pacemaker systems. Storage requires adherence to sterile packaging guidelines to maintain integrity prior to use.