← Product Code [LDF](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/LDF) · K801800 # UNIVERSAL TEMP. PACING ELECT. #080-10000 (K801800) _Medical Testing System, Inc. · LDF · Oct 23, 1980 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/LDF/K801800 ## Device Facts - **Applicant:** Medical Testing System, Inc. - **Product Code:** [LDF](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/LDF.md) - **Decision Date:** Oct 23, 1980 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.3680 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Regulatory Identification Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/LDF/K801800](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/LDF/K801800) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/LDF/K801800