← Product Code [KRB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB) · K791026

# 4F STERILE BALLOON-LESS, CATHETER 913-28 (K791026)

_Waters Assoc., Inc. · KRB · Jun 22, 1979 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K791026

## Device Facts

- **Applicant:** Waters Assoc., Inc.
- **Product Code:** [KRB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB.md)
- **Decision Date:** Jun 22, 1979
- **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.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K791026](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRB/K791026)

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