Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4310](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4310) → DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass

# DXS · Gauge, Pressure, Coronary, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4310 · Class 2_

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

## Overview

- **Product Code:** DXS
- **Device Name:** Gauge, Pressure, Coronary, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4310](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4310)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A cardiopulmonary bypass coronary pressure gauge is a device used in cardiopulmonary bypass surgery to measure the pressure of the blood perfusing the coronary arteries.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K113235](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K113235.md) | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS | Medtronic, Inc. | Dec 2, 2011 | SESE |
| [K944764](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K944764.md) | VTI DISPOSABLE PRESSURE DISPLAY SET | Vascular Technology Incorporated | Dec 27, 1994 | SESE |
| [K912045](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K912045.md) | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | Lifestream Int'L, Inc. | Oct 31, 1991 | SESE |
| [K900797](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K900797.md) | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | Shiley, Inc. | May 10, 1990 | SESE |
| [K873802](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K873802.md) | PRESSURE BARRIER KIT CAT. NO. PBK-3 | American Omni Medical, Inc. | Nov 6, 1987 | SESE |
| [K862836](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K862836.md) | STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE | Shiley, Inc. | Sep 12, 1986 | SESE |
| [K852232](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K852232.md) | PRESSURE DISPLAY BOX #60000/TUBING SET #61000 | Dlp, Inc. | Aug 9, 1985 | SESE |
| [K842194](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K842194.md) | PRESSURE MONITOR | Norton Texas Medical Products | Aug 27, 1984 | SESE |
| [K831750](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K831750.md) | PM-3 | Delta Medical Industries | Jul 26, 1983 | SESE |
| [K822822](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K822822.md) | GAMBRO PRESSURE MONITOR PRM 10 | Gambro, Inc. | Oct 18, 1982 | SESE |
| [K820912](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K820912.md) | PMS-2 PRESSURE MONITOR SEPARATOR | Delta Medical Industries | May 18, 1982 | SESE |
| [K781890](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K781890.md) | CHAMBER, MC-1 DISPOSABLE PRESSURE | Delta Medical Industries | Dec 4, 1978 | SESE |
| [K771764](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXS/K771764.md) | CORONARY PRESSURE PERFUSION PUMP | 3M Health Care, Sarns | Sep 30, 1977 | SESE |

## Top Applicants

- Delta Medical Industries — 3 clearances
- Shiley, Inc. — 2 clearances
- Vascular Technology Incorporated — 1 clearance
- Norton Texas Medical Products — 1 clearance
- Medtronic, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com