Resterilization of Implantable Electrode
510(k) K800891
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800891 | Date28 May 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- Withdrawn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
- 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, 20 Sep 2026
This device is a Permanent Pacemaker Electrode designed for resterilization and reuse in cardiovascular applications. Implantable electrodes are used to deliver electrical impulses to the heart for pacing purposes, ensuring proper heart rhythm regulation in patients with bradycardia or other conduction disorders. The process involves cleaning, sterilizing, and reprocessing electrodes to extend their usability while maintaining safety and efficacy standards.
The resterilization process is intended for clinical settings, particularly in low-resource environments, where electrodes may be reprocessed for reuse. Supplied as a Class III device under FDA regulation 870.3680, it adheres to FDA 510(k) clearance (K800891) with a Substantially Equivalent (SESE) determination. The device is not described as single-use or sterile out-of-package, and no MRI safety classification is provided. Storage and handling must comply with reprocessing protocols to ensure sterility and functionality prior to reuse.