DXS · Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4310 · Class 2
Overview
| Product Code | DXS |
|---|---|
| Device Name | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4310 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS | Medtronic, Inc. | Dec 2, 2011 | SESE |
| K944764 | VTI DISPOSABLE PRESSURE DISPLAY SET | Vascular Technology Incorporated | Dec 27, 1994 | SESE |
| K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | Lifestream Int'L, Inc. | Oct 31, 1991 | SESE |
| K900797 | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | Shiley, Inc. | May 10, 1990 | SESE |
| K873802 | PRESSURE BARRIER KIT CAT. NO. PBK-3 | American Omni Medical, Inc. | Nov 6, 1987 | SESE |
| K862836 | STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE | Shiley, Inc. | Sep 12, 1986 | SESE |
| K852232 | PRESSURE DISPLAY BOX #60000/TUBING SET #61000 | Dlp, Inc. | Aug 9, 1985 | SESE |
| K842194 | PRESSURE MONITOR | Norton Texas Medical Products | Aug 27, 1984 | SESE |
| K831750 | PM-3 | Delta Medical Industries | Jul 26, 1983 | SESE |
| K822822 | GAMBRO PRESSURE MONITOR PRM 10 | Gambro, Inc. | Oct 18, 1982 | SESE |
| K820912 | PMS-2 PRESSURE MONITOR SEPARATOR | Delta Medical Industries | May 18, 1982 | SESE |
| K781890 | CHAMBER, MC-1 DISPOSABLE PRESSURE | Delta Medical Industries | Dec 4, 1978 | SESE |
| K771764 | 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
