← Product Code [MGZ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ) · K925283

# VALVULOTOME (K925283)

_Intramed Laboratories, Inc. · MGZ · Feb 10, 1994 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K925283

## Device Facts

- **Applicant:** Intramed Laboratories, Inc.
- **Product Code:** [MGZ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ.md)
- **Decision Date:** Feb 10, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4885
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An external vein stripper is an extravascular device used to remove a section of a vein.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K925283](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MGZ/K925283)

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