TMP Pressure Isolatorr, TMP Pressure Monitor Syst
FDA 510(k) K912045 · Lifestream Int'L, Inc.
510(k) numberK912045
Submission
- Device name
- TMP Pressure Isolatorr, TMP Pressure Monitor Syst
- Applicant
- Lifestream Int'L, Inc.
The Woodlands, TX, US - Received
- May 8, 1991
- Decision date
- October 31, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4310
- Specialty
- Cardiovascular
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|---|---|---|---|
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| K944764 | Vti Disposable Pressure Display SetDXS · Traditional | Vascular Technology Incorporated | 12/27/1994SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | Shiley, Inc. | 05/10/1990SE |
| K873802 | Pressure Barrier Kit Cat. No. PBK-3DXS · Traditional | American Omni Medical, Inc. | 11/06/1987SE |
| K862836 | Stockert-Shiley Caps and Caps Dual Pressure ModuleDXS · Traditional | Shiley, Inc. | 09/12/1986SE |
| K852232 | Pressure Display Box #60000/TUBING Set #61000DXS · Traditional | Dlp, Inc. | 08/09/1985SE |
| K842194 | Pressure MonitorDXS · Traditional | Norton Texas Medical Products | 08/27/1984SE |
| K831750 | PM-3DXS · Traditional | Delta Medical Industries | 07/26/1983SE |
| K822822 | Gambro Pressure Monitor PRM 10DXS · Traditional | Gambro, Inc. | 10/18/1982SE |
| K820912 | PMS-2 Pressure Monitor SeparatorDXS · Traditional | Delta Medical Industries | 05/18/1982SE |
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Questions and answers
When was TMP Pressure Isolatorr, TMP Pressure Monitor Syst cleared by the FDA?
TMP Pressure Isolatorr, TMP Pressure Monitor Syst (K912045) received a 510(k) decision of Substantially Equivalent on October 31, 1991, 176 days after the submission was received.
What is the product code of K912045?
The FDA product code is DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4310.