← Product Code [KRB](/productcode/KRB) · K812800

# FLOW-DIRECTED THERMODILUTION CATHETER (K812800)

_Sorensen Research · KRB · Oct 20, 1981 · Cardiovascular · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K812800

## Device Facts

- **Applicant:** Sorensen Research
- **Product Code:** [KRB](/productcode/KRB.md)
- **Decision Date:** Oct 20, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1915
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.

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**Source:** [https://fda-staging.innolitics.com/device/K812800](https://fda-staging.innolitics.com/device/K812800)

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