Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1340](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1340) → OFJ — Lead Introducer Kit

# OFJ · Lead Introducer Kit

_Cardiovascular · 21 CFR 870.1340 · Class 2_

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

## Overview

- **Product Code:** OFJ
- **Device Name:** Lead Introducer Kit
- **Regulation:** [21 CFR 870.1340](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1340)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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