DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass Class II
FDA product code DXS covers "Gauge, Pressure, Coronary, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4310. Submissions are reviewed by the Cardiovascular panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DXS
- Device Class
- Class II
- Regulation Number
- 870.4310
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K113235 | medtronic | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS | December 2, 2011 |
| K944764 | vascular technology incorporated | VTI DISPOSABLE PRESSURE DISPLAY SET | December 27, 1994 |
| K912045 | lifestream int'l | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | October 31, 1991 |
| K900797 | shiley | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | May 10, 1990 |
| K873802 | american omni medical | PRESSURE BARRIER KIT CAT. NO. PBK-3 | November 6, 1987 |
| K862836 | shiley | STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE | September 12, 1986 |
| K852232 | dlp | PRESSURE DISPLAY BOX #60000/TUBING SET #61000 | August 9, 1985 |
| K842194 | norton texas medical products | PRESSURE MONITOR | August 27, 1984 |
| K831750 | delta medical industries | PM-3 | July 26, 1983 |
| K822822 | gambro | GAMBRO PRESSURE MONITOR PRM 10 | October 18, 1982 |
| K820912 | delta medical industries | PMS-2 PRESSURE MONITOR SEPARATOR | May 18, 1982 |
| K781890 | delta medical industries | CHAMBER, MC-1 DISPOSABLE PRESSURE | December 4, 1978 |
| K771764 | 3m health care, sarns | CORONARY PRESSURE PERFUSION PUMP | September 30, 1977 |