Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3545](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3545) → PCK — Pediatric Ventricular Assist Device

# PCK · Pediatric Ventricular Assist Device

_Cardiovascular · 21 CFR 870.3545 · Class f_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PCK

## Overview

- **Product Code:** PCK
- **Device Name:** Pediatric Ventricular Assist Device
- **Regulation:** [21 CFR 870.3545](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3545)
- **Device Class:** f
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PCK](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PCK)

**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