CENTRAL VENOUS PRESSURE MANOMETER
FDA 510(k) clearance K904674 · decided 1990-12-27
Clearance details
- K-number
- K904674
- Device name
- CENTRAL VENOUS PRESSURE MANOMETER
- Applicant
- Medex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-12
- Decision date
- 1990-12-27
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- KRK
- Device class
- 2
- Regulation number
- 870.1140
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dublin, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medex
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UST-5268P-5 TRANSDUCER (K950607) | Aloka Co., Ltd. | 1995-09-15 |
| ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK (K884386) | Ethitek Pharmaceuticals Co. | 1989-01-05 |
| MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER (K875322) | Schneider-Shilley (Usa) | 1988-03-28 |
| SCHNEIDER-SHILEY PRESSURE MANOMETER (K861605) | Shiley, Inc. | 1986-05-28 |
| MANOMETER SET C.V.P. #S 298/299 (K830910) | Exco, Inc. | 1983-04-05 |
| MEDIFIX (K813498) | Burron Medical Products, Inc. | 1982-01-07 |
| MEDIFIX GRADUATED SCALE (K813195) | Burron Medical Products, Inc. | 1981-12-29 |
| VENOUS PRESSURE MONITOR, MF 35 LF (K790668) | Deco Medical, Inc. | 1979-05-23 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed te recall (Z-0812-06) | Medex Inc | 2006-04-26 |