Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4875](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4875) → QTF — Reprocessed Atherectomy Catheter

# QTF · Reprocessed Atherectomy Catheter

_Cardiovascular · 21 CFR 870.4875 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/QTF

## Overview

- **Product Code:** QTF
- **Device Name:** Reprocessed Atherectomy Catheter
- **Regulation:** [21 CFR 870.4875](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4875)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K220171](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/QTF/K220171.md) | NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter | Northeast Scientific, Inc. | Jul 1, 2022 | SESE |

## Top Applicants

- Northeast Scientific, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/QTF](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/QTF)

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