← Product Code [DTP](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP) · K910568

# MODEL 5866-46 SLEEVE KIT (K910568)

_Medtronic Vascular · DTP · Apr 9, 1991 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K910568

## Device Facts

- **Applicant:** Medtronic Vascular
- **Product Code:** [DTP](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP.md)
- **Decision Date:** Apr 9, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4230
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K910568](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTP/K910568)

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