Permanent & Temporary Pacemaker Electrode
by Diag Corp. 510(k)
Active
510(k) K820262
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820262 | Date12 Mar 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Permanent & Temporary Pacemaker Electr.
- 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, classified under FDA regulation 870.3680, designed to deliver electrical pacing stimuli to the heart. It consists of flexible, insulated electrical conductors connecting an external pulse generator to cardiac tissue, enabling temporary or permanent cardiac pacing in patients with arrhythmias. The electrode facilitates synchronized contractions by transmitting pacing impulses directly to the heart muscle, supporting normal cardiac rhythm when native conduction is impaired.
The device is intended for use in hospital settings by cardiologists and electrophysiologists, typically during procedures requiring temporary cardiac support or as part of permanent pacing systems. Supplied as a reusable medical device (as indicated by the absence of single-use descriptors), it must be sterilized and handled according to standard medical device protocols. The electrode is regulated under FDA 510(k) clearance (K820262) and falls under Device Class III, reflecting its critical role in cardiac function. No third-party review was required for this submission.
Other devices from Diag Corp.
Questions
AI-generated answers, 20 Sep 2026
Is this pacemaker electrode designed for single-use or can it be reused after sterilization?
This device is explicitly labeled as a reusable pacemaker electrode. Since it is not described as single-use and falls under standard reusable medical device protocols, it must be sterilized and handled according to established medical device reprocessing guidelines before each use.
What types of healthcare settings or professionals are authorized to use this pacemaker electrode?
The device is intended for use in hospital settings by cardiologists and electrophysiologists, particularly during procedures requiring temporary cardiac support or as part of permanent pacing systems. Its classification and regulatory history reflect its critical role in specialized cardiac care.
How is this electrode regulated by the FDA, and what does that mean for its use?
This pacemaker electrode is regulated under FDA 510(k) clearance (K820262) and classified as a Class III device, indicating it is subject to strict regulatory oversight due to its role in sustaining life or supporting critical bodily functions. The clearance was granted under the Traditional 510(k) pathway, meaning it was deemed Substantially Equivalent to a legally marketed predicate device, ensuring compliance with safety and performance standards.
What medical specialties or clinical scenarios would this electrode be relevant for?
This electrode is designed for patients with arrhythmias where native cardiac conduction is impaired, enabling temporary or permanent pacing to restore synchronized heart contractions. It is specifically relevant in cardiovascular procedures, including temporary support during surgeries or as part of permanent pacemaker systems, as indicated by its regulatory classification and the advisory committee designation.