Home / 510(k) Clearances / K955816

510(k) K955816

VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR by Baxter Healthcare Corp — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1997
Date Received
December 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

Other clearances by Baxter Healthcare Corp

  • K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap E (March 12, 2024)
  • K192705 — MiniCap Extended Life PD Transfer Sets (October 25, 2019)
  • K190910 — PrisMax System Version 2 (July 25, 2019)
  • K163530 — PrisMax Control Unit (May 3, 2017)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)
  • K130531 — ULTRAFUSE (April 8, 2014)
  • K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION (October 8, 2013)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)
  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (January 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (January 8, 2013)

Other clearances for product code DYG

  • K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphe (December 9, 2024)
  • K233983 — Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F (June 27, 2024)
  • K233824 — Swan-Ganz catheter (June 6, 2024)
  • K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanc (September 21, 2023)
  • K222117 — Swang-Ganz IQ pulmonary artery catheter (December 9, 2022)
  • K193466 — Swan-Ganz Catheters (February 16, 2020)
  • K160084 — Swan Ganz Catheters (May 3, 2016)
  • K094048 — PERCUPRO MESSENGER BALLOON CATHETER (July 14, 2011)
  • K081052 — OCCLUSION BALLOON CATHETER, MODEL VENOS (June 18, 2008)
  • K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ (March 19, 2002)