Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5830](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5830) → SHJ — Thrombectomy Whole Blood Return System

# SHJ · Thrombectomy Whole Blood Return System

_Anesthesiology · 21 CFR 868.5830 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/SHJ

## Overview

- **Product Code:** SHJ
- **Device Name:** Thrombectomy Whole Blood Return System
- **Regulation:** [21 CFR 868.5830](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5830)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253717](/device/K253717.md) | Helo™ Return | Endovascular Engineering, Inc. | Oct 11, 2026 | SESE |

## Top Applicants

- Endovascular Engineering, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/SHJ](https://fda.innolitics.com/productcode/SHJ)

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