Manometer, Blood-Pressure, Venous
FDA product code KRK · Class II (moderate risk) · 21 CFR 870.1140 · Cardiovascular
9510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950607 | UST-5268P-5 TransducerKRK · Traditional | Aloka Co., Ltd. | 09/15/1995SE |
| K904674 | Central Venous Pressure ManometerKRK · Traditional | Medex, Inc. | 12/27/1990SE |
| K884386 | Administration/Manometer Set W/3 Way StopcockKRK · Traditional | Ethitek Pharmaceuticals Co. | 01/05/1989SE |
| K875322 | Modified Schneider-Shiley Pressure ManometerKRK · Traditional | Schneider-Shilley (Usa) | 03/28/1988SE |
| K861605 | Schneider-Shiley Pressure ManometerKRK · Traditional | Shiley, Inc. | 05/28/1986SE |
| K830910 | Manometer Set C.V.P. #S 298/299KRK · Traditional | Exco, Inc. | 04/05/1983SE |
| K813498 | MedifixKRK · Traditional | Burron Medical Products, Inc. | 01/07/1982SE |
| K813195 | Medifix Graduated ScaleKRK · Traditional | Burron Medical Products, Inc. | 12/29/1981SE |
| K790668 | Venous Pressure Monitor, MF 35 LFKRK · Traditional | Deco Medical, Inc. | 05/23/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1421-2018 Class II | Manometer, 550 ml three-Way Stopcock; STERILE;The integrity of the sterile packaging is potentially compromised. | Carefusion 2200 Inc | 02/23/2017Terminated |