Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3935](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3935) → DTJ — Holder, Heart-Valve, Prosthesis

# DTJ · Holder, Heart-Valve, Prosthesis

_Cardiovascular · 21 CFR 870.3935 · Class 1_

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

## Overview

- **Product Code:** DTJ
- **Device Name:** Holder, Heart-Valve, Prosthesis
- **Regulation:** [21 CFR 870.3935](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3935)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

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

## Classification Rationale

Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K962154](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K962154.md) | CARBOMEDICS HANDLE | Carbomedics, Inc. | Aug 27, 1996 | SESE |
| [K960169](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K960169.md) | CARBOMEDICS VALVE TESTER | Carbomedics, Inc. | Apr 15, 1996 | SESE |
| [K944214](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K944214.md) | BAXTER HANDLE MODEL 1150 | Baxter Edwards | Feb 10, 1995 | SESE |
| [K942736](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K942736.md) | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Carbomedics, Inc. | Jul 6, 1994 | SESE |
| [K880052](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K880052.md) | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR | Baxter Healthcare Corp | Apr 1, 1988 | SESE |
| [K871596](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K871596.md) | IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) | Shiley, Inc. | Jun 15, 1987 | SESE |
| [K864155](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K864155.md) | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS | American Edwards Laboratories | Nov 20, 1986 | SESE |
| [K813276](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K813276.md) | IONESCU-SHILEY VALVE HOLDER & HANDLE | Shiley, Inc. | Dec 10, 1981 | SESE |
| [K811236](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K811236.md) | DISPOSABLE HOLDER FOR HANCOCK AORTIC | Vascor, Inc. | May 13, 1981 | SESE |
| [K811235](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K811235.md) | DISPOSABLE HOLDER FOR HANCOCK MITRAL | Vascor, Inc. | May 13, 1981 | SESE |
| [K792034](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K792034.md) | INTEGRAL DISPOSABLE HOLDER CARPENTIER | Edwards Laboratories | Dec 7, 1979 | SESE |
| [K790022](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTJ/K790022.md) | DISPOSABLE HOLDER FOR BIOPROSTHESIS | Edwards Laboratories | Jan 15, 1979 | SESE |

## Top Applicants

- Carbomedics, Inc. — 3 clearances
- Edwards Laboratories — 2 clearances
- Shiley, Inc. — 2 clearances
- Vascor, Inc. — 2 clearances
- American Edwards Laboratories — 1 clearance

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

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