Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3945](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3945) → DTI — Sizer, Heart-Valve, Prosthesis

# DTI · Sizer, Heart-Valve, Prosthesis

_Cardiovascular · 21 CFR 870.3945 · Class 1_

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

## Overview

- **Product Code:** DTI
- **Device Name:** Sizer, Heart-Valve, Prosthesis
- **Regulation:** [21 CFR 870.3945](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3945)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K952184](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K952184.md) | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | Carbomedics, Inc. | Nov 29, 1995 | SESE |
| [K934951](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K934951.md) | VALVE SIZER | Carbomedics, Inc. | Dec 10, 1993 | SESE |
| [K881279](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K881279.md) | EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET | Baxter Healthcare Corp | May 18, 1988 | SESE |
| [K853313](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K853313.md) | DUROMEDICS CARDIAC VALVE SIZER SET | Hemex Scientific, Inc. | Nov 1, 1985 | SESE |
| [K852612](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K852612.md) | METRONIC MODEL F7700 HEART VALVE SIZERS | Medtronic Vascular | Sep 23, 1985 | SESE |
| [K820887](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K820887.md) | MITRAL VALVE ORIFICE SIZER | Celtech | Jul 8, 1982 | SESE |
| [K801885](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DTI/K801885.md) | HANCOCK * OBTURATORS | Hancock Laboratories, Inc. | Sep 9, 1980 | SESE |

## Top Applicants

- Carbomedics, Inc. — 2 clearances
- Baxter Healthcare Corp — 1 clearance
- Celtech — 1 clearance
- Hancock Laboratories, Inc. — 1 clearance
- Hemex Scientific, Inc. — 1 clearance

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

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