← Product Code [DWE](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWE) · K800178

# EXTRACORP.'S INTERSEPT CUS. TUBING PK. (K800178)

_Extracorporeal Medical Specialities, Inc. · DWE · Feb 21, 1980 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWE/K800178

## Device Facts

- **Applicant:** Extracorporeal Medical Specialities, Inc.
- **Product Code:** [DWE](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWE.md)
- **Decision Date:** Feb 21, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4390
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWE/K800178](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWE/K800178)

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