Home / 510(k) Clearances / K904674

510(k) K904674

CENTRAL VENOUS PRESSURE MANOMETER by Medex, Inc. — Product Code KRK

K904674 is an FDA 510(k) premarket notification submitted by Medex, Inc. for the device "CENTRAL VENOUS PRESSURE MANOMETER". The FDA issued a decision of Substantially Equivalent on December 27, 1990. The device falls under product code KRK (Manometer, Blood-Pressure, Venous), a Class II device regulated under 21 CFR 870.1140. Medex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1990
Date Received
October 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manometer, Blood-Pressure, Venous
Device Class
Class II
Regulation Number
870.1140
Review Panel
CV
Submission Type

Other clearances by Medex, Inc.

  • K242255 — Qitexio® 4-Way Stopcock (QIT014) (April 29, 2025)
  • K203738 — Qitexio (March 14, 2022)
  • K042432 — PHARMGUARD TOOLBOX, MODEL G6000782 (January 4, 2005)
  • K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (April 30, 2004)
  • K020780 — TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP (May 20, 2002)
  • K000328 — MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP (May 9, 2000)
  • K982640 — MEDEX 3000 SERIES SYRINGE INFUSION PUMP (April 6, 1999)
  • K982123 — CONTRAST CONTROL DEVICE (July 21, 1998)
  • K955231 — MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP (July 18, 1996)
  • K961404 — MX960 REUSABLE PRESSURE TRANSDUCER (June 27, 1996)

Other clearances for product code KRK

  • K950607 — UST-5268P-5 TRANSDUCER (September 15, 1995)
  • K884386 — ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK (January 5, 1989)
  • K875322 — MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER (March 28, 1988)
  • K861605 — SCHNEIDER-SHILEY PRESSURE MANOMETER (May 28, 1986)
  • K830910 — MANOMETER SET C.V.P. #S 298/299 (April 5, 1983)
  • K813498 — MEDIFIX (January 7, 1982)
  • K813195 — MEDIFIX GRADUATED SCALE (December 29, 1981)
  • K790668 — VENOUS PRESSURE MONITOR, MF 35 LF (May 23, 1979)

FDA data resources