KRK · Manometer, Blood-Pressure, Venous
Cardiovascular · 21 CFR 870.1140 · Class 2
Overview
| Product Code | KRK |
|---|---|
| Device Name | Manometer, Blood-Pressure, Venous |
| Regulation | 21 CFR 870.1140 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950607 | UST-5268P-5 TRANSDUCER | Aloka Co., Ltd. | Sep 15, 1995 | SESE |
| K904674 | CENTRAL VENOUS PRESSURE MANOMETER | Medex, Inc. | Dec 27, 1990 | SESE |
| K884386 | ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK | Ethitek Pharmaceuticals Co. | Jan 5, 1989 | SESE |
| K875322 | MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER | Schneider-Shilley (Usa) | Mar 28, 1988 | SESE |
| K861605 | SCHNEIDER-SHILEY PRESSURE MANOMETER | Shiley, Inc. | May 28, 1986 | SESE |
| K830910 | MANOMETER SET C.V.P. #S 298/299 | Exco, Inc. | Apr 5, 1983 | SESE |
| K813498 | MEDIFIX | Burron Medical Products, Inc. | Jan 7, 1982 | SESE |
| K813195 | MEDIFIX GRADUATED SCALE | Burron Medical Products, Inc. | Dec 29, 1981 | SESE |
| K790668 | VENOUS PRESSURE MONITOR, MF 35 LF | Deco Medical, Inc. | May 23, 1979 | SESE |
Top Applicants
- Burron Medical Products, Inc. — 2 clearances
- Aloka Co., Ltd. — 1 clearance
- Deco Medical, Inc. — 1 clearance
- Ethitek Pharmaceuticals Co. — 1 clearance
- Exco, Inc. — 1 clearance
