Home / 510(k) Clearances / K112203

510(k) K112203

COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST by Mirador Biomedical, Inc. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2011
Date Received
August 1, 2011
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 Mirador Biomedical, Inc.

  • K133624 — COMPASS CT, COMPASS CT PORT (April 18, 2014)
  • K103715 — COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE (January 20, 2011)
  • K101518 — COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE (October 13, 2010)

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)