Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1220](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1220) → NLG — Catheter, Intracardiac Mapping, High-Density, Reprocessed

# NLG · Catheter, Intracardiac Mapping, High-Density, Reprocessed

_Cardiovascular · 21 CFR 870.1220 · Class 2_

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

## Overview

- **Product Code:** NLG
- **Device Name:** Catheter, Intracardiac Mapping, High-Density, Reprocessed
- **Regulation:** [21 CFR 870.1220](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1220)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K212776](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NLG/K212776.md) | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | Dec 20, 2021 | SESE |
| [K211662](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NLG/K211662.md) | Reprocessed IntellaMap Orion High Resolution Mapping Catheter | Innovative Health, LLC | Nov 18, 2021 | SESE |
| [K190785](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/NLG/K190785.md) | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Innovative Health, LLC | Jun 25, 2019 | SESE |

## Top Applicants

- Innovative Health, LLC — 3 clearances

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

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