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510(k) K133624

COMPASS CT, COMPASS CT PORT by Mirador Biomedical — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2014
Date Received
November 26, 2013
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

  • K112203 — COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSU (December 14, 2011)
  • K103715 — COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE (January 20, 2011)
  • K101518 — COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE (October 13, 2010)

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  • 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)
  • K123095 — MEDLINE BLOOD PRESSURE TRANSDUCER (May 8, 2013)
  • K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (June 8, 2012)