← Product Code [DTI](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI) · K853313

# DUROMEDICS CARDIAC VALVE SIZER SET (K853313)

_Hemex Scientific, Inc. · DTI · Nov 1, 1985 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K853313

## Device Facts

- **Applicant:** Hemex Scientific, Inc.
- **Product Code:** [DTI](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI.md)
- **Decision Date:** Nov 1, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3945
- **Device Class:** Class 1
- **Review Panel:** Cardiovascular

## Regulatory Identification

A prosthetic heart valve sizer is a device used to measure the size of the natural valve opening to determine the size of the appropriate replacement heart valve.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K853313](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K853313)

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