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) → NQG — Stabilizer, Heart, Non-Compression, Reprocessed

# NQG · Stabilizer, Heart, Non-Compression, Reprocessed

_Cardiovascular · 21 CFR 870.4500 · Class 1_

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

## Overview

- **Product Code:** NQG
- **Device Name:** Stabilizer, Heart, Non-Compression, Reprocessed
- **Regulation:** [21 CFR 870.4500](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4500)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K070036](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/NQG/K070036.md) | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES | Ascent Healthcare Solutions | Aug 17, 2007 | SESE |
| [K070034](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/NQG/K070034.md) | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES | Ascent Healthcare Solutions | Aug 17, 2007 | SESE |
| [K063844](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/NQG/K063844.md) | REPROCESSED HEART STABILIZERS AND POSITIONERS | Sterilmed, Inc. | Mar 15, 2007 | SESE |

## Top Applicants

- Ascent Healthcare Solutions — 2 clearances
- Sterilmed, Inc. — 1 clearance

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

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