COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE

Transducer, Blood-pressure, Extravascular

MIRADOR BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Mirador Biomedical, Inc. with the FDA for Compass Vascular Access / Access Port / Lumbar Puncture / Intracranial Pressure.

Pre-market Notification Details

Device IDK103715
510k NumberK103715
Device Name:COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
ClassificationTransducer, Blood-pressure, Extravascular
Applicant MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle,  WA  98102
ContactJustin Hulvershorn
CorrespondentJustin Hulvershorn
MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle,  WA  98102
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-21
Decision Date2011-01-20

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