← Product Code [DTS](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS) · K905008

# FLEXIBLE INTRACARDIAC SUCTION DEVICE (K905008)

_Gish Biomedical, Inc. · DTS · Jan 23, 1991 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K905008

## Device Facts

- **Applicant:** Gish Biomedical, Inc.
- **Product Code:** [DTS](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS.md)
- **Decision Date:** Jan 23, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4420
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.

## 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/DTS/K905008](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K905008)

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