Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4430](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4430) → DWD — Suction Control, Intracardiac, Cardiopulmonary Bypass

# DWD · Suction Control, Intracardiac, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4430 · Class 2_

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

## Overview

- **Product Code:** DWD
- **Device Name:** Suction Control, Intracardiac, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4430](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4430)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

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

## 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 (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K992657](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K992657.md) | IBC VRV, MODEL 1350 | International Biophysics Corp. | Feb 18, 2000 | SESE |
| [K920077](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K920077.md) | NIKKISO NK PUMP | International Medical Products, Inc. | Sep 29, 1993 | SESE |
| [K915482](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K915482.md) | B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 7, 1992 | SESE |
| [K915481](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K915481.md) | B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 7, 1992 | SESE |
| [K915480](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K915480.md) | B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 7, 1992 | SESE |
| [K905311](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K905311.md) | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. | Baxter Bentley Laboratories, Inc. | Jan 15, 1991 | SESE |
| [K895427](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K895427.md) | MEDISEAL SUCTION CANISTER | Deroyal Industries, Inc. | Jan 19, 1990 | SESE |
| [K864503](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K864503.md) | MODIFIED RLV-2100 B | American Omni Medical, Inc. | Jan 6, 1987 | SESE |
| [K863593](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K863593.md) | SARNS SAFETY LOOP | 3M Health Care, Sarns | Nov 18, 1986 | SESE |
| [K862540](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K862540.md) | LEFT VENTRICULAR VENT VALVE MODEL NO. GLV | Gish Biomedical, Inc. | Aug 29, 1986 | SESE |
| [K861428](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K861428.md) | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 | American Omni Medical, Inc. | Jun 26, 1986 | SESE |
| [K851406](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K851406.md) | AJDJUSTABLE SUCTION CONTROL VALVE | American Omni Medical, Inc. | Aug 5, 1985 | SESE |
| [K830150](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K830150.md) | VEINPREP VEIN GRAFT PREP. KIT A277723 | Atrium Medical Corp. | Feb 28, 1983 | SESE |
| [K830149](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K830149.md) | IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- | Instrumentation Laboratory CO | Feb 28, 1983 | SESE |
| [K760894](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DWD/K760894.md) | VACUUM RELIEF VALVE | Delta Medical Industries | Dec 9, 1976 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- American Omni Medical, Inc. — 3 clearances
- International Medical Products, Inc. — 1 clearance
- International Biophysics Corp. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance

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

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