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) → LXN — Probe, Test, Heart-Valve

# LXN · Probe, Test, Heart-Valve

_Cardiovascular · 21 CFR 870.4500 · Class 1_

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

## Overview

- **Product Code:** LXN
- **Device Name:** Probe, Test, Heart-Valve
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K890165](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/LXN/K890165.md) | FORCEPS-ORTHOPEDIC | Dhason Brothers, Inc. | Feb 13, 1989 | SESE |
| [K881449](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/LXN/K881449.md) | EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 | Baxter Healthcare Corp | Jun 15, 1988 | SESE |

## Top Applicants

- Baxter Healthcare Corp — 1 clearance
- Dhason Brothers, Inc. — 1 clearance

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

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