← Product Code [DYG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG) · K812111

# PRUITT ARTERIAL OCCLUSION CHOLANG. CATH (K812111)

_Bionomy, Inc. · DYG · Nov 16, 1981 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K812111

## Device Facts

- **Applicant:** Bionomy, Inc.
- **Product Code:** [DYG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG.md)
- **Decision Date:** Nov 16, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1240
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K812111](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K812111)

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