Pressure Barrier Kit Cat. No. PBK-3
FDA 510(k) K873802 · American Omni Medical, Inc.
510(k) numberK873802
Submission
- Device name
- Pressure Barrier Kit Cat. No. PBK-3
- Applicant
- American Omni Medical, Inc.
Costa Mesa, CA, US - Received
- September 18, 1987
- Decision date
- November 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4310
- Specialty
- Cardiovascular
Other 510(k)s with product code DXS
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|---|---|---|---|
| K113235 | Pressure Display Box,Dlp Disposable Pressure Display Sets-Non Sterile VersionsDXS · Special | Medtronic, Inc. | 12/02/2011SE |
| K944764 | Vti Disposable Pressure Display SetDXS · Traditional | Vascular Technology Incorporated | 12/27/1994SE |
| K912045 | TMP Pressure Isolatorr, TMP Pressure Monitor SystDXS · Traditional | Lifestream Int'L, Inc. | 10/31/1991SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | Shiley, Inc. | 05/10/1990SE |
| 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 |
More from Delta Medical Industries
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|---|---|---|
| K922781 | Flow Conrol ValveMJJ · Traditional | 03/08/1993SE |
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| K900672 | Prebypass Filter, Cat. No. FPB-5KRJ · Traditional | 04/03/1990SE |
| K884893 | Cardiotomy Reservoir Valve No. CRV-30 or PCRV-25KRI · Traditional | 01/30/1989SE |
| K884640 | Cardioplegia Overpressure Valve CPOP-350 & 700KRI · Traditional | 01/24/1989SE |
| K873316 | Bubble Trap-Filter Cat. No B180F37DTM · Traditional | 07/14/1988SE |
| K875080 | Air Vent Line Cat. No. AVL-36DTM · Traditional | 02/29/1988SE |
| K873610 | Pediatric Bubble Trap Cat. No. B-100BSY · Traditional | 11/05/1987SE |
| K873488 | Silent Guard Cat. No. SG-10DTL · Traditional | 10/07/1987SE |
| K871632 | Nasogastric VoicetubeBTR · Traditional | 09/16/1987SE |
Questions and answers
When was Pressure Barrier Kit Cat. No. PBK-3 cleared by the FDA?
Pressure Barrier Kit Cat. No. PBK-3 (K873802) received a 510(k) decision of Substantially Equivalent on November 6, 1987, 49 days after the submission was received.
What is the product code of K873802?
The FDA product code is DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4310.