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510(k) K944764

VTI DISPOSABLE PRESSURE DISPLAY SET by Vascular Technology Incorporated — Product Code DXS

K944764 is an FDA 510(k) premarket notification submitted by Vascular Technology Incorporated for the device "VTI DISPOSABLE PRESSURE DISPLAY SET". The FDA issued a decision of Substantially Equivalent on December 27, 1994. The device falls under product code DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4310. Vascular Technology Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1994
Date Received
September 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4310
Review Panel
CV
Submission Type

Other clearances by Vascular Technology Incorporated

  • K082870 — VTI INTRAOPERATIVE DOPPLER SYSTEMS (October 28, 2008)
  • K031091 — VTI 20 MHZ GATED DOPPLER (April 23, 2003)
  • K002990 — VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 (November 6, 2000)
  • K922738 — VTI OXYGEN ANALYZER (January 27, 1993)
  • K890058 — VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM (November 21, 1989)
  • K883960 — GIPHY MONITOR (October 4, 1989)
  • K864583 — CARDIAC PERFORMANCE MONITOR (May 11, 1987)
  • K862114 — KHURI REGIONAL TISSUE PH MONITOR (June 25, 1986)
  • K862113 — NO. 100352 GALVANIC OXYGEN SENSOR (June 19, 1986)
  • K852275 — VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR (June 20, 1985)

Other clearances for product code DXS

  • K113235 — PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS (December 2, 2011)
  • K912045 — TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST (October 31, 1991)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)
  • K873802 — PRESSURE BARRIER KIT CAT. NO. PBK-3 (November 6, 1987)
  • K862836 — STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE (September 12, 1986)
  • K852232 — PRESSURE DISPLAY BOX #60000/TUBING SET #61000 (August 9, 1985)
  • K842194 — PRESSURE MONITOR (August 27, 1984)
  • K831750 — PM-3 (July 26, 1983)
  • K822822 — GAMBRO PRESSURE MONITOR PRM 10 (October 18, 1982)
  • K820912 — PMS-2 PRESSURE MONITOR SEPARATOR (May 18, 1982)

FDA data resources