← Product Code [DRB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB) · K000366

# FIXATION STYLETS, MODELS 335-287 AND 335-288 (K000366)

_Accufix Research Institute · DRB · Apr 14, 2000 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K000366

## Device Facts

- **Applicant:** Accufix Research Institute
- **Product Code:** [DRB](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB.md)
- **Decision Date:** Apr 14, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1380
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K000366](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRB/K000366)

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