Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4500](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4500) → MWS — Stabilizer, Heart

# MWS · Stabilizer, Heart

_Cardiovascular · 21 CFR 870.4500 · Class 1_

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

## Overview

- **Product Code:** MWS
- **Device Name:** Stabilizer, Heart
- **Regulation:** [21 CFR 870.4500](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4500)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K041338](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MWS/K041338.md) | MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES | Medtronic Vascular | Jul 19, 2004 | SESE |
| [K992476](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MWS/K992476.md) | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | Pilling Weck Surgical | Sep 13, 2000 | SESE |
| [K992833](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MWS/K992833.md) | VACUUM ASSIST STABILIZER | Cardio Thoracic Systems | Nov 10, 1999 | SESE |
| [K982419](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MWS/K982419.md) | HEART-LIFT BALLOON POSITIONER | Cardiothoracic Systems, Inc. | Jan 13, 1999 | SESE |

## Top Applicants

- Pilling Weck Surgical — 1 clearance
- Medtronic Vascular — 1 clearance
- Cardiothoracic Systems, Inc. — 1 clearance
- Cardio Thoracic Systems — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com