Product code KRK— Cardiovascular
ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK
- Classification name
- Manometer, Blood-Pressure, Venous
- Device class
- Class 2
- Regulation
- 21 CFR 870.1140
- Advisory panel
- Cardiovascular
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code KRK
FDA has cleared devices under product code KRK between 1979 and 1995, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1995
- 1990
- 1989
- 1988
- 1986
- 1983
- 1982
- 1981
- 1979
Top applicants under product code KRK
Recent clearances under product code KRK
- K950607 — UST-5268P-5 TRANSDUCER
- K904674 — CENTRAL VENOUS PRESSURE MANOMETER
- K884386 — ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK
- K875322 — MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER
- K861605 — SCHNEIDER-SHILEY PRESSURE MANOMETER
- K830910 — MANOMETER SET C.V.P. #S 298/299
- K813498 — MEDIFIX
- K813195 — MEDIFIX GRADUATED SCALE
- K790668 — VENOUS PRESSURE MONITOR, MF 35 LF
Data sourced from openFDA. This site is unofficial and independent of the FDA.