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


Device Classification Name

transducer, blood-pressure, extravascular

510(k) Number K103715
Device Name COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
Applicant
MIRADOR BIOMEDICAL, INC.
2815 wastlake avenue
suite 300
seattle, 
WA 
98102

Applicant Contact justin hulvershorn
Correspondent
MIRADOR BIOMEDICAL, INC.
2815 wastlake avenue
suite 300
seattle, 
WA 
98102

Correspodent Contact justin hulvershorn
Regulation Number 870.2850
Classification Product Code
DRS  
Subsequent Product Code
DXG  
Date Received 12/21/2010
Decision Date 01/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No