← Product Code [DRE](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE) · K841995

# 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK (K841995)

_Quinton, Inc. · DRE · Jul 2, 1984 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K841995

## Device Facts

- **Applicant:** Quinton, Inc.
- **Product Code:** [DRE](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE.md)
- **Decision Date:** Jul 2, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1310
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K841995](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRE/K841995)

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