← Product Code [DTR](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR) · K823533

# JACKET & SET (K823533)

_Shiley, Inc. · DTR · Dec 30, 1982 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K823533

## Device Facts

- **Applicant:** Shiley, Inc.
- **Product Code:** [DTR](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR.md)
- **Decision Date:** Dec 30, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4240
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K823533](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTR/K823533)

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