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) → DWX — Stripper, Artery, Intraluminal

# DWX · Stripper, Artery, Intraluminal

_Cardiovascular · 21 CFR 870.4875 · Class 2_

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

## Overview

- **Product Code:** DWX
- **Device Name:** Stripper, Artery, Intraluminal
- **Regulation:** [21 CFR 870.4875](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4875)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## 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 (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K121415](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K121415.md) | MOLLRING MULTITASC | LeMaitre Vascular, Inc. | Sep 5, 2012 | SESE |
| [K032105](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K032105.md) | ENDOHELIX ENDARTERECTOMY DEVICE | Endarx, Inc. | Oct 30, 2003 | SESE |
| [K020925](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K020925.md) | CARBODISSECTING ENDOSCOPE | Endo Surgical Devices, Inc. | Apr 29, 2003 | SESE |
| [K003719](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K003719.md) | VASCULAR ARCHITECTS PERISCOPE DEVICE | Vascular Architects, Inc. | Feb 28, 2001 | SESE |
| [K950813](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K950813.md) | MOLLRING CUTTER | Cardio Vascular Concepts, Inc. | Jul 25, 1995 | SESE |
| [K933498](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K933498.md) | EXTERNAL VEIN STRIPPER | Applied Medical Resources | Mar 23, 1994 | SESE |
| [K913803](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K913803.md) | INTRALUMINAL ARTERY STRIPPER | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | Apr 24, 1992 | SESE |
| [K911099](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K911099.md) | MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE | Pilling Co. | Jun 25, 1991 | SESE |
| [K904944](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K904944.md) | TRANSLUMINAL ENDARTERECTOMY DEVICE | Baxter Healthcare Corp | Dec 17, 1990 | SESE |
| [K895878](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K895878.md) | OLYMPUS VALVULOTOME W/DETACHABLE TIP | Olympus Corp. | Jan 2, 1990 | SESE |
| [K894496](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K894496.md) | OLYMPUS VALVULOTOME W/FIXED TIP | Olympus Corp. | Oct 12, 1989 | SESE |
| [K890515](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K890515.md) | PERIPHERAL ATHERECTOMY SYSTEM | Intensive Technology, Inc. | May 23, 1989 | SESE |
| [K841521](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K841521.md) | SCANLAN ENDARSECTOR | Scanlan Intl., Inc. | Aug 3, 1984 | SESE |
| [K801063](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWX/K801063.md) | HALL ARTERIAL OSCILLATOR | American Sterilizer Co. | Sep 26, 1980 | SESE |

## Top Applicants

- Olympus Corp. — 2 clearances
- American Sterilizer Co. — 1 clearance
- Applied Medical Resources — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Cardio Vascular Concepts, Inc. — 1 clearance

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

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