← Product Code [DTJ](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ) · K942736

# CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE (K942736)

_Carbomedics, Inc. · DTJ · Jul 6, 1994 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K942736

## Device Facts

- **Applicant:** Carbomedics, Inc.
- **Product Code:** [DTJ](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ.md)
- **Decision Date:** Jul 6, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3935
- **Device Class:** Class 1
- **Review Panel:** Cardiovascular

## Regulatory Identification

A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K942736](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K942736)

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