510(k) K912045
- Device
- TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
- Applicant
- LIFESTREAM INT'L, INC.
- 510(k) number
- K912045
- Product code
- DXS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-10-31
- Date received
- 1991-05-08
- Regulation
- 870.4310
- Classification name
- Gauge, Pressure, Coronary, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KRISTA OAKES
- Address
- 2828 N.Crescent River Dr. The Woodlands TX US 77381 77381
FDA Registration Numbers#
- 1649914
- 2184009
- 3003955307
- 1928237
Source Documents#
Other 510(k) Records For Product Code DXS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K113235 | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS | Medtronic, Inc. | 2011-12-02 |
| K944764 | VTI DISPOSABLE PRESSURE DISPLAY SET | Vascular Technology Incorporated | 1994-12-27 |
| K900797 | STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR | Shiley, Inc. | 1990-05-10 |
| K873802 | PRESSURE BARRIER KIT CAT. NO. PBK-3 | American Omni Medical, Inc. | 1987-11-06 |
| K862836 | STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE | Shiley, Inc. | 1986-09-12 |
| K852232 | PRESSURE DISPLAY BOX #60000/TUBING SET #61000 | Dlp, Inc. | 1985-08-09 |
| K842194 | PRESSURE MONITOR | Norton Texas Medical Products | 1984-08-27 |
| K831750 | PM-3 | Delta Medical Industries | 1983-07-26 |
| K822822 | GAMBRO PRESSURE MONITOR PRM 10 | Gambro, Inc. | 1982-10-18 |
| K820912 | PMS-2 PRESSURE MONITOR SEPARATOR | Delta Medical Industries | 1982-05-18 |
| K781890 | CHAMBER, MC-1 DISPOSABLE PRESSURE | Delta Medical Industries | 1978-12-04 |
| K771764 | CORONARY PRESSURE PERFUSION PUMP | 3M Health Care, Sarns | 1977-09-30 |
Legacy Summary#
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FDA Review#
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