← Product Code [DYG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG) · K901247

# TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES (K901247)

_Intec Medical, Inc. · DYG · Jul 31, 1990 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K901247

## Device Facts

- **Applicant:** Intec Medical, Inc.
- **Product Code:** [DYG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG.md)
- **Decision Date:** Jul 31, 1990
- **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/K901247](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K901247)

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