Manometer, Blood-Pressure, Venous
This device is a venous blood pressure manometer used to measure central venous pressure in hospitalized patients, providing critical hemodynamic data for fluid management and cardiovascular monitoring. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRK, regulated under 21 CFR 870.1140 within the Cardiovascular specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KRK
- Device Class
- FDA class 2
- Regulation Number
- 870.1140
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950607 | UST-5268P-5 TRANSDUCER | Sep 15, 1995 | Substantially Equivalent | Aloka Co., Ltd. |
| K904674 | CENTRAL VENOUS PRESSURE MANOMETER | Dec 27, 1990 | Substantially Equivalent | Medex, Inc. |
| K884386 | ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK | Jan 05, 1989 | Substantially Equivalent | Ethitek Pharmaceuticals Co. |
| K875322 | MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER | Mar 28, 1988 | Substantially Equivalent | Schneider-Shilley (Usa) |
| K861605 | SCHNEIDER-SHILEY PRESSURE MANOMETER | May 28, 1986 | Substantially Equivalent | Shiley, Inc. |
| K830910 | MANOMETER SET C.V.P. #S 298/299 | Apr 05, 1983 | Substantially Equivalent | Exco, Inc. |
| K813498 | MEDIFIX | Jan 07, 1982 | Substantially Equivalent | Burron Medical Products, Inc. |
| K813195 | MEDIFIX GRADUATED SCALE | Dec 29, 1981 | Substantially Equivalent | Burron Medical Products, Inc. |
| K790668 | VENOUS PRESSURE MONITOR, MF 35 LF | May 23, 1979 | Substantially Equivalent | Deco Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.