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510(k) K101518

COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE by Mirador Biomedical, Inc. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2010
Date Received
June 2, 2010
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)
  • 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)

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  • K161408 — Compass Cast and MAP (November 22, 2016)
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  • 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)