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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter for crossing total occlusions
510(k) Number K120533
Device Name BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
Original Applicant
BRIDGEPOINT MEDICAL
13355 10th ave n,
suite #110
plymouth,  MN  55441
Original Contact jill munsinger
Regulation Number870.1250
Classification Product Code
PDU  
Date Received02/22/2012
Decision Date 05/22/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT01246505
Reviewed by Third Party No
Combination Product No
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