← Product Code [DQE](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE) · K905458

# SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER (K905458)

_Baxter Healthcare Corp · DQE · Feb 7, 1991 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K905458

## Device Facts

- **Applicant:** Baxter Healthcare Corp
- **Product Code:** [DQE](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE.md)
- **Decision Date:** Feb 7, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1230
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K905458](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K905458)

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