← Product Code [DWB](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB) · K831458

# CARDIOPLEGIA RECIRCULATION SYS-BL 705/A (K831458)

_Electromedics, Inc. · DWB · Oct 20, 1983 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K831458

## Device Facts

- **Applicant:** Electromedics, Inc.
- **Product Code:** [DWB](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB.md)
- **Decision Date:** Oct 20, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4370
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K831458](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWB/K831458)

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