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) → OFC — Catheter Introducer Kit

# OFC · Catheter Introducer Kit

_Cardiovascular · 21 CFR 870.1340 · Class 2_

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

## Overview

- **Product Code:** OFC
- **Device Name:** Catheter 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K093257](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OFC/K093257.md) | TORQMAX SHEATH GRIP ACCESSORY | Spectranetics Corp. | Mar 26, 2010 | SESE |

## Top Applicants

- Spectranetics Corp. — 1 clearance

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

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