← Product Code [DTZ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ) · K803231

# THB 6000 HARDSHELL BUBBLE OXYGENATOR (K803231)

_Travenol Laboratories, S.A. · DTZ · Jan 16, 1981 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K803231

## Device Facts

- **Applicant:** Travenol Laboratories, S.A.
- **Product Code:** [DTZ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ.md)
- **Decision Date:** Jan 16, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4350
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K803231](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTZ/K803231)

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