← Product Code [DWD](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD) · K895427

# MEDISEAL SUCTION CANISTER (K895427)

_Deroyal Industries, Inc. · DWD · Jan 19, 1990 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K895427

## Device Facts

- **Applicant:** Deroyal Industries, Inc.
- **Product Code:** [DWD](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD.md)
- **Decision Date:** Jan 19, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4430
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return sucker.

## Special Controls

*Classification.* Class II (special 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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K895427](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K895427)

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