Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4500](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4500) → OFA — Cardiovascular Surgical Instruments Tray

# OFA · Cardiovascular Surgical Instruments Tray

_Cardiovascular · 21 CFR 870.4500 · Class 1_

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

## Overview

- **Product Code:** OFA
- **Device Name:** Cardiovascular Surgical Instruments Tray
- **Regulation:** [21 CFR 870.4500](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4500)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

## 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 (0 of 0)

_No cleared devices on record._

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

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