← Product Code [DWC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC) · K945720

# JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE (K945720)

_Jostra Bentley · DWC · Mar 29, 1995 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K945720

## Device Facts

- **Applicant:** Jostra Bentley
- **Product Code:** [DWC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC.md)
- **Decision Date:** Mar 29, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4250
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K945720](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWC/K945720)

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