Home / 510(k) Clearances / K872596

510(k) K872596

TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 by American Edwards Laboratories — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1987
Date Received
July 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
Review Panel
CV
Submission Type

Other clearances by American Edwards Laboratories

  • K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER (December 3, 1987)
  • K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 (September 15, 1987)
  • K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP (April 17, 1987)
  • K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP (February 27, 1987)
  • K864330 — SHEAR FORCE GAUGE (January 6, 1987)
  • K862724 — VEIN VALVE CUTTER (January 2, 1987)
  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K863596 — CHIN-FOGARTY INFLATION DEVICE (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)
  • K862872 — FLEXIBLE VISUALIZATION CATHETER (October 24, 1986)

Other clearances for product code DRS

  • K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (March 21, 2025)
  • K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes (March 17, 2023)
  • K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (November 9, 2017)
  • K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw (May 24, 2017)
  • K161408 — Compass Cast and MAP (November 22, 2016)
  • K152472 — Disposable Pressure Transducer (October 31, 2016)
  • K152980 — Flo Trac sensor, Volume View sensor (January 19, 2016)
  • K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pre (September 4, 2015)
  • K133624 — COMPASS CT, COMPASS CT PORT (April 18, 2014)
  • K123095 — MEDLINE BLOOD PRESSURE TRANSDUCER (May 8, 2013)