← Product Code [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF) · K931794

# MARINR SERIES EP DIAGNOSTIC CATHETERS (K931794)

_Medtronic Cardiorhythm · DRF · Jun 6, 1994 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K931794

## Device Facts

- **Applicant:** Medtronic Cardiorhythm
- **Product Code:** [DRF](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF.md)
- **Decision Date:** Jun 6, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1220
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K931794](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K931794)

**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:** Innolitics at https://innolitics.com