Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4420](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4420) → DTS — Sucker, Cardiotomy Return, Cardiopulmonary Bypass

# DTS · Sucker, Cardiotomy Return, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4420 · Class 2_

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

## Overview

- **Product Code:** DTS
- **Device Name:** Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4420](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4420)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K053021](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K053021.md) | ESTECH CLEARVIEW MV ATRIAL DEPRESSOR | Estech, Inc. | Jan 26, 2006 | SESE |
| [K982891](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K982891.md) | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS | California Medical Laboratories, Inc. | Sep 30, 1998 | SESE |
| [K963756](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K963756.md) | IBC CARDIAC SUCTION WARD | International Biophysics Corp. | Nov 14, 1997 | SESE |
| [K905008](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K905008.md) | FLEXIBLE INTRACARDIAC SUCTION DEVICE | Gish Biomedical, Inc. | Jan 23, 1991 | SESE |
| [K900339](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K900339.md) | HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES | Shiley, Inc. | Mar 28, 1990 | SESE |
| [K891906](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K891906.md) | ROBICSEK INTRACARDIAC SUCTION WAND | Gish Biomedical, Inc. | Jun 13, 1989 | SESE |
| [K801641](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K801641.md) | OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT | Ohio Medical Products | Jul 28, 1980 | SESE |
| [K801400](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K801400.md) | DISPOSABLE SUCKER SYSTEM | Texas Medical Products, Inc. | Jun 30, 1980 | SESE |
| [K791846](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTS/K791846.md) | DISPOSSABLE SUCTION TUBE, 6 FRENCH | Dlp, Inc. | Oct 2, 1979 | SESE |

## Top Applicants

- Gish Biomedical, Inc. — 2 clearances
- Texas Medical Products, Inc. — 1 clearance
- Shiley, Inc. — 1 clearance
- Ohio Medical Products — 1 clearance
- International Biophysics Corp. — 1 clearance

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

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