← Product Code [DWS](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS) · K844584

# GORE-TEX TUNNELER (K844584)

_W. L. Gore & Associates, Inc. · DWS · Jan 24, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K844584

## Device Facts

- **Applicant:** W. L. Gore & Associates, Inc.
- **Product Code:** [DWS](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS.md)
- **Decision Date:** Jan 24, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4500
- **Device Class:** Class 1
- **Review Panel:** Cardiovascular

## Regulatory Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K844584](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWS/K844584)

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